louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02538016: TCUPS- Tolvaptan Use in Cystinuria and Urolithiasis: A Pilot Study
Official title: Use of Tolvaptan, a Vasopressin Antagonist, to Increase Urine Dilution and Reduce Cystine Urolithiasis Among Patients With Homozygous Cystinuria: a Pilot Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystinuria
Keywords: Cystinuria
Kidney Stones
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Otsuka America Pharmaceutical
First posted: 2015-09-02
Enrollment: 4
Sex: ALL
Minimum age (years): 12
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this research project is to establish that in short-term use, tolvaptan is a safe and potentially effective new therapy for cystinuria, by conducting a short-term pilot study of the safety and tolerability of this drug, and assess impact on urinary stone risk parameters, among adolescent and young adult patients with clinical cystinuria.


Eligibility criteria: Inclusion Criteria:

* Males and females age 12 - 29 years
* Weight ≥ 25kg (55 lbs)
* Confirmed cystinuria diagnosis
* Specific blood test levels (done within the past 6 months)

Exclusion Criteria:

* Concurrent non-renal disease that might increase risk of complications due to aquaresis
* Liver or biliary disease (chronic or acute)
* Malabsorption syndrome or other gastrointestinal condition that may interfere with response to therapy
* Non-cutaneous malignancy within last 5 years
* History of adverse reaction or allergy to Tolvaptan or other arginine vasopressin V2-receptor antagonists

Primary outcomes:
measure: Urinary Cystine Supersaturation (mg/L) at High Dose (Day7-8)
timeFrame: 23 days
Secondary outcomes:
measure: Urine Osmolality at High Dose (Day 8)
timeFrame: 11 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Caleb Nelson, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02830516: Intraoperative Measurement of Lung Elastance and Transpulmonary Pressure Using Two Different Methods.
Official title: Intraoperative Measurement of Lung Elastance and Transpulmonary Pressure Using Two Different Methods
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2016-07-13
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients which are anesthetized and muscle relaxed and are planned to undergo major surgery

Brief summary: Classically lung elastance and transpulmonary pressure are measured from the difference in tidal variations of airway pressure subtracted by tidal variations i esophagus pressure divided by the tidal volume. This requires the presence of a esophageal balloon catheter which is cumbersome and costly. In this study values obtained as described above are compared to values obtained with a new method in which a stepwise increase in positive endexpiratory pressure (PEEP) is performed with a size which corresponds to the tidal volume which the patient is ventilated with. These measurements are performed in anesthetized patients prior to major surgery.

Detailed description: Classically lung elastance and transpulmonary pressure are measured from the difference in tidal variations of airway pressure subtracted by tidal variations in esophageal pressure divided by the tidal volume (Method 1). This requires the presence of a esophageal balloon catheter which is cumbersome and costly.

In this study values obtained as described in Method 1 above are compared to values obtained with a new method in which a PEEP-step is performed with a size which corresponds to the tidal volume which the patient is ventilated with. Measurements using Method 1 and 2 are performed in anesthetized patients prior to major surgery.

Eligibility criteria: Inclusion Criteria:

* Patient undergoing major surgery during anesthesia and muscle relaxation

Exclusion Criteria:

* Patient with chronic obstructive lung disease

Primary outcomes:
measure: Measurement of lung elastance
timeFrame: At 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: Sahlgrenska University Hospital
name: Stefan Lundin, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Persson P, Stenqvist O, Lundin S. Evaluation of lung and chest wall mechanics during anaesthesia using the PEEP-step method. Br J Anaesth. 2018 Apr;120(4):860-867. doi: 10.1016/j.bja.2017.11.076. Epub 2017 Dec 1.
Clinical trial NCT04992416: Immediately Placed Implants Using Simvastatin and Autogenous Tooth Graft Combination in Periodontally Compromised Sites
Official title: Immediately Placed Implants Using Simvastatin and Autogenous Tooth Graft Combination in Periodontally Compromised Sites: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autogenous Tooth Bone Graft
Immediate Implant Placement
Simvastatin
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2021-08-05
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recently, autogenous tooth graft (ATG) made from compromised teeth was applied in bone defects and resulted in a good clinical efficacy.(6) Moreover, it is more accepted by patients to use extracted teeth as a bone graft material, especially in the case of immediate implant placement. Simvastatin (SMV), known as a 3-hydroxy-3-methylglutaryl-CoA (HMG-CoA) reductase inhibitor, is widely used to decrease serum cholesterol because of its safe and effective treatment. Apart from cholesterol-lowering effects, SMV is also found to promote osteogenic differentiation of bone marrow stem cells (BMSCs), suppress osteoclastic differentiation in bone tissue and promotes osseointegration around implants in animal studies. SMV is reported to enhance autophagy and alleviates the ROS of BMSCs in the osseointegration of implants. The present study will be carried out to evaluate the effect of SMV combined with ATG on bone formation around immediately placed dental implants.


Eligibility criteria: Inclusion Criteria:

* Teeth need to be extracted for periodontal reasons with a defect of labial bone (horizontal or vertical bone defect).
* the teeth without acute inflammation.
* no uncontrolled systemic disease which is not suitable for implantation.
* Good systemic and oral health.

Exclusion Criteria:

* patients with systemic diseases or medications known to alter healing processes.
* Psychiatric disorders.
* Root canal treated teeth.
* patients undergoing or who had undergone radiation therapy and chemotherapy to the head and neck region during 12 months.
* patients with para-functional habits.
* alcoholics.
* drug abusers.
* heavy smokers

Primary outcomes:
measure: clinical evaluation of bone formation around immediately placed dental implants
timeFrame: 9 months
measure: radiographic outcome around immediately placed dental implants
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Faculty of Dentistry, Kafrelsheikh University
Study officials:
affiliation: Kafrelsheikh University
name: Dalia R Issa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06436716: Artificial Intelligence Model for Traumatic Cervical Spinal Cord Injury Based on Radiomics and Genomics
Official title: The Second Affiliated Hospital of Nantong University, Nantong First People's Hospital, Nantong University
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spinal Cord Injuries
Lead sponsor: Affiliated 2 Hospital of Nantong University
Sponsor class: OTHER
First posted: 2024-05-31
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: MRI image of patients within 48 hours after TCSCI in The First People's Hospital of Nantong

Brief summary: Collect standardized, structured, and comprehensive disease-specific information, produce high-quality and accurate clinical data, provide a sample basis for the analysis and mining of spinal cord injury clinical big data, and establish a spinal cord injury-specific disease data platform to serve clinical work. Promote multi-center cooperation in spinal cord injury research: Establish a unified, standardized, queryable, and sharable efficient spinal cord clinical research data platform to promote multi-center cooperation in spinal cord injury clinical research and enhance the international competitiveness of this research field. Help the region to prepare for the establishment of a spinal cord injury-specific disease data platform for various hospitals in the region, forming a spinal cord injury-specific disease network center to achieve data sharing.


Eligibility criteria: Inclusion Criteria:

1. MRI Diagnosis of TCSCI
2. Clinic Diagnosis of TCSCI
3. The injury site must be in cervical spinal cord
4. MRI images of T2WI must be collected within 48 hours after injury
5. Complete and available imaging data, clinical data, including MRI, sex, age

Exclusion Criteria:

1. Spinal cord concussion and MRI scans have no obvious positive performance of spinal cord
2. The quality of MRI images is insufficient or there are serious motion artifacts

Primary outcomes:
measure: MRI image
timeFrame: From 2016 to 2027
measure: ASIA scores
timeFrame: From 2016 to 2027
Secondary outcomes:
measure: Age
timeFrame: From 2016 to 2027
measure: Gender
timeFrame: From 2016 to 2027
measure: Weight
timeFrame: From 2016 to 2027
measure: Height
timeFrame: From 2016 to 2027
measure: BMI
timeFrame: From 2016 to 2027
Other outcomes:
Locations:
city: Nantong
country: China
facility: Affiliated 2 Hospital of Nantong University
state: Jiangsu
Study officials:
References:
Clinical trial NCT00569816: Continuous Versus Repetitive Sevoflurane Administration for Preconditioning
Official title: A Comparison Between Continuous and Repetitive Sevoflurane Administration for Preconditioning During Coronary Artery Bypass Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myocardial Injury
Keywords: myocardial protection
pharmacological preconditioning
volatile anesthetics
myocardial injury following CABG surgery
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
Collaborators: name: Department of Anaesthesiology and Intensive Care Medicine
name: Abbott
First posted: 2007-12-07
Enrollment: 50
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: Pharmacologic preconditioning by volatile anesthetics may depend on the mode of administration. The researchers hypothesize that a continuous administration in patients scheduled for CABG surgery prebypass will be less effective in terms of attenuating myocardial cell damage compared to a repetitive administration with a double wash in/wash out schedule. A control group will receive propofol as their primary anesthetic.


Eligibility criteria: Inclusion Criteria:

* Patients schedulded to undergo CABG surgery
* Age 18 to 80 years
* Ejection fraction \> 40%

Exclusion Criteria:

* Emergency cases
* Diabetes
* Not able to give informed consent
* Ejection fraction \< 40%

Primary outcomes:
measure: Myocardial cell damage as assessed by plasma levels of Troponin T
timeFrame: from induction of anesthesia until hospital discharge
Secondary outcomes:
measure: Length of stay on the ICU and in the hospital
timeFrame: from hospital admission until hospital discharge
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: University Hospital Schleswig-Holstein, Campus Kiel
Study officials:
affiliation: University Hospital Schleswig-Holstein, Campus Kiel, Department of Anaesthesiology and Intensive Care Medicine
name: Jens Scholz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00172016: A Study to Evaluate the Efficacy and Tolerability of Zoledronic Acid in Patients With Metastatic Prostate Cancer Who Can be Treated With a Group of Medications Known as Bisphosphonates
Official title: A Study to Evaluate the Efficacy and Tolerability of Zoledronic Acid in Patients With Metastatic Prostate Cancer Who Can be Treated With a Group of Medications Known as Bisphosphonates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prostate Cancer With at Least One Bone Lesion in Patients Receiving Hormonal Therapy and Treatment With Bisphosphonates is Indicated
Keywords: Zoledronic acid
SRE
Prostate cancer
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 43
Sex: MALE
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: The purpose of this study is to assess the efficacy and tolerability of zoledronic acid in preventing skeletal-related events in patients with prostate cancer


Eligibility criteria: Inclusion Criteria:

* Written informed consent must be obtained
* Age \> 18 years
* Histologically confirmed diagnosis of carcinoma of the prostate
* Current (or previous) objective evidence of metastatic disease to the bone
* Currently receiving 1st line hormonal therapy with LHRH agonists or other hormonal treatments
* ECOG performance status of 0, 1, or 2

Exclusion Criteria:

* Patients with abnormal renal function as evidenced by either a serum creatinine determination 1.5 x or greater above the upper limit of normal or by a calculated creatinine clearance of 60 ml/minute or less
* Corrected (adjusted for serum albumin) serum calcium concentration \< 8.0 mg/dl (2.00 mmol/L)
* WBC\<3.0x1'000'000'000, ANC \< 1500/mm3, Hgb\<8.0 g/dL, platelets \< 75 x 1'000'000'000/L.
* Liver function tests \>2.5 ULN, serum creatinine \>1.5 ULN.
* Patients with another nonmalignant disease which would confound the evaluation of primary endpoints or prevent the patient complying with the protocol.
* Known hypersensitivity to zoledronic acid or other bisphosphonates
* Subjects who, in the opinion of the investigator, are unlikely to cooperate fully during the study

Other protocol-defined inclusion / exclusion criteria apply.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT02592616: Interval-training and Appetite Regulation in Patients With Type 2 Diabetes
Official title: Interval-training and Appetite Regulation in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Exercise
Appetite
Energy intake
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2015-10-30
Enrollment: 14
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Four months of interval walking (IW) training results in substantial weight loss in opposition to energy-expenditure matched continuous walking (CW) training. The reason for this is unclear.

This study will assess if IW leads to greater exercise-induced suppression of appetite and ad libitum food intake compared to CW and no exercise.

Subjects with type 2 diabetes will be included in a crossover, counter-balanced, controlled study, where each subject will undergo three trials. Trials will be identical except the following interventions:

1. One hour of rest (CON)
2. One hour of interval walking (repeated cycles of 3 min of fast and 3 min of slow walking; IW)
3. One hour of continuous walking (CW) matched to IW with regards to energy-expenditure.

After the interventions subjects will undergo a liquid mixed meal tolerance test (450 kCal), with regular measurements of appetite-related hormones (insulin, ghrelin, Leptin, Cholecystokinin, PYY). Three hours into the mixed meal tolerance test, a standardised ad-libitum meal test will be served and intake will recorded. Free-living energy intake via food records will be assessed during the following 32 hours.


Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes Mellitus
* BMI \> 25

Exclusion Criteria:

* Pregnancy
* Smoking
* Contraindication to increased levels of physical activity
* Eating disorder
* Insulin dependence

Primary outcomes:
measure: Ad-libitum meal energy intake
timeFrame: Initiated 3 hours after the intervention
Secondary outcomes:
measure: Free-living energy intake
timeFrame: For 32 hours following the ad-libitum meal.
measure: Appetite-related hormones
timeFrame: Regularly during the 3 hours following the intervention
measure: Satiety
timeFrame: Regular assessments for 36 hours following the intervention
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Center for Physical Activity Research (CFAS)
Study officials:
References:
Clinical trial NCT04231916: High Resolution Thermal Imaging to Identify Vertebral Fractures in Children and Young People With Osteogenesis Imperfecta
Official title: High Resolution Thermal Imaging to Identify Vertebral Fractures in Children and Young People With Osteogenesis Imperfecta
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteogenesis Imperfecta
Lead sponsor: Sheffield Children's NHS Foundation Trust
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 11
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: Brittle bone disease also known as osteogenesis imperfecta (OI) is characterised by a defect in the bone tissue that leads to recurrent fractures and significant bone deformities in children. These fractures include vertebral (spinal) fractures. As a result, child with OI require regular clinic surveillance that includes repeated xrays of the spine. in our pilot study the investigators plan to use a thermal imaging camera that can pick up changes in temperature to 0.03 degrees to determine whether the investigators can accurately identify vertebral fractures without the need for radiation. in the first part of the study the investigators will compare the thermal images from the camera with the xrays to see if the investigators can pick up the vertebral fractures seen on the xray picture. If this is possible, then the investigators will move on to phase 2 of the study which will investigate the ability of the thermal camera to pick up vertebral fractures without prior knowledge of where the fractures are located. If this approach is successful this will help us to develop a nonradiation, lowcost painless way of identifying vertebral fractures in children with OI.


Eligibility criteria: * Patients with Osteogenesis Imperfecta (with known vertebral fractures)for phase one of the study.
* Patients with Osteogenesis Imperfecta for phase 2 of the study
* In both groups patients will be aged 5 years and over

Primary outcomes:
measure: Thermal imaging device
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02006316: Beneficial Effects of Microsurgical Varicocelectomy on Semen Parameters for Causes Other Than Infertility
Official title: Beneficial Effects of Microsurgical Varicocelectomy on Semen Parameters in Patients Who Underwent Surgery for Causes Other Than Infertility
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Varicocele
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-12-10
Enrollment: 121
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: men with clinical varicoceles underwent microsurgical varicocelectomy due to causes other than infertility such as testicular pain, discomfort or scrotal mass

Brief summary: The purpose of this study is to evaluate whether clinical varicoceles are associated with abnormal semen parameters and whether varicocelectomy could improve the semen parameter in patients unrelated with infertility.

Detailed description: While most studies are continued to validate the observations of significant improvements in sperm density and motility after varicocele ligation in infertile patients, there have been few studies to investigate the effects of varicocelectomy on semen parameters in adult men unrelated with infertility. The purpose of this study was to determine whether varicocelectomy could improve the semen parameter of these patients as well as whether clinical varicoceles are associated with abnormal semen parameters in patients unrelated with infertility.

Eligibility criteria: Inclusion Criteria:

* men with clinical varicoceles underwent microsurgical varicocelectomy due to causes other than infertility such as testicular pain, discomfort or scrotal mass

Exclusion Criteria:

* adolescents
* men with proven fertility or azoospermia
* men with preoperative normal sperm analysis
* available data to compare between preoperative and postoperative semen analyses

Primary outcomes:
measure: Sperm concentration, motility, and morphology
timeFrame: at postoperative 4months
Secondary outcomes:
measure: whether semen analysis should be done in men with clinical varicocele regardless of the chief complaint
timeFrame: at postoperative 4months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Soo Woong Kim, M.D.,Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT04711616: Physical Therapy Interventions Following Arthroscopic Rotator Cuff Repair
Official title: Physical Therapy Interventions Following Arthroscopic Rotator Cuff Repair: A Prospective Single Group Interventional Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Injuries
Pain, Postoperative
Kinesiophobia
Lead sponsor: Sahmyook University
Sponsor class: OTHER
First posted: 2021-01-15
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In the post-arthroscopic rotator cuff repair (ARCR) management, physical therapy intervention is an important factor in bringing about a clinically positive prognosis. However, no conclusive therapeutic evidence has been found for various physical therapy interventions. In this study, the investigators would like to investigate the effects of physical therapy interventions on ARCR patients.


Eligibility criteria: Inclusion Criteria:

* Adults over 18 years old
* In case of 2 weeks after receiving arthroscopic rotator cuff repair
* When the participants wishes to enroll in the study

Exclusion Criteria:

* 65 years old or older
* If the tear area is large and augmentation is performed
* If there is a previous surgical history at the surgical site
* Osteoarthritis in the shoulder joint

Primary outcomes:
measure: Pain intensity
timeFrame: Change from baseline pain intensity at 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: The Better Hospital
Study officials:
References: