louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02813239: Dual Triggering in Patients With a High Immature Oocyte Rate
Official title: Dual Triggering With Gonadotropin-releasing Hormone Agonist and Standard Dose Human Chorionic Gonadotropin in Patients With a High Immature Oocyte Rate
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: INFERTILITY
Keywords: IVF
Dual trigger
GnRH agonist
hCG
mature oocytes
Lead sponsor: IVI Madrid
Sponsor class: OTHER
First posted: 2016-06-24
Enrollment: 81
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women undergoing controlled ovarian stimulation with a high immature oocyte rate

Brief summary: In in vitro fertilization (IVF) cycles, even after adequate triggering, some patients present a high rate of immature oocytes retrieved after controlled ovarian stimulation. In vitro oocyte maturation is still an experimental technique, with poorer results than conventional IVF. For that reason improve in in vivo maturation could have a better impact on reproductive outcome.

Detailed description: Investigators performed an observational study analyzing the difference in the percentage of mature oocytes retrieved in patients with more than 50% immature oocytes in a previous IVF cycle triggered with human chorionic gonadotropin (rhCG) compared to the rate of mature oocytes retrieved in subsequent cycles, triggered with both gonadotropin-releasing hormone agonist (GnRHa) and (hCG). The main outcome measure was the number and percentage of mature oocytes retrieved.

Eligibility criteria: Inclusion Criteria:

* BMI of 18-30 kg/m2
* Male factor required for ICSI

Exclusion Criteria:

-

Primary outcomes:
measure: Metaphase II rate
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: IVI Madrid
name: Juan Antonio Garcia Velasco, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fatemi HM, Garcia-Velasco J. Avoiding ovarian hyperstimulation syndrome with the use of gonadotropin-releasing hormone agonist trigger. Fertil Steril. 2015 Apr;103(4):870-3. doi: 10.1016/j.fertnstert.2015.02.004. Epub 2015 Feb 24.
citation: Kohls G, Ruiz F, Martinez M, Hauzman E, de la Fuente G, Pellicer A, Garcia-Velasco JA. Early progesterone cessation after in vitro fertilization/intracytoplasmic sperm injection: a randomized, controlled trial. Fertil Steril. 2012 Oct;98(4):858-62. doi: 10.1016/j.fertnstert.2012.05.046. Epub 2012 Jun 29.
Clinical trial NCT06142539: The Impact of Different Scanning Methods and Reconstruction Algorithms on CT Image Quality
Official title: The Impact of Different Scanning Methods and Reconstruction Algorithms on CT Image Quality
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: CT Examination of the Abdomen
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2023-11-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Abdominal CT examination

Brief summary: Purpose: To evaluate the image quality of deep learning-based image reconstruction (DLIR) algorithm in unenhanced abdominal low-dose CT (LDCT).

Methods: CT images of a phantom were reconstructed with Hybrid iterative reconstruction and deep learning image reconstruction (DLIR). The noise power spectrum (NPS) and task transfer function (TTF) were measured. Two patient groups were included in this study: consecutive patients who underwent unenhanced abdominal standard-dose CT reconstructed with hybrid iterative reconstruction (SDCT group) and consecutive patients who underwent unenhanced abdominal LDCT reconstructed of HIR and DLIR (LDCT group). The CT values, standard deviation (SD), signal-to-noise ratio (SNR), and contrast-to-noise ratio (CNR) of the hepatic parenchyma and paraspinal muscle and abdominal subcutaneous fat were evaluated. Radiologists assessed the subjective image quality and lesion diagnostic confidence using a 5-point Likert scale. Quantitative and qualitative parameters were compared between SDCT and LDCT groups.


Eligibility criteria: Inclusion Criteria:

Abdominal CT examination

Exclusion Criteria:

pregnancy and lactation for women unstable breath holding

Primary outcomes:
measure: Results of phantom research
timeFrame: up to six months
measure: Results of human clinical study
timeFrame: up to six months
Secondary outcomes:
measure: Patient demographics
timeFrame: up to six months
Other outcomes:
Locations:
city: Shandong
country: China
facility: uCT960+
state: Jinan Shandong
Study officials:
References:
Clinical trial NCT05482139: Incisional Hernia Repair With Mesh at Waitemata District Health Board - A 15 Year Retrospective Cohort Study'
Official title: Incisional Hernia Repair With Mesh at Waitemata District Health Board - A 15 Year Retrospective Cohort Study'
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Incisional Hernia
Lead sponsor: Waitemata District Health Board
Sponsor class: OTHER_GOV
First posted: 2022-08-01
Enrollment: 718
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who had an incisional hernia repair with mesh at WDHB between January 2004 and July 2019

Brief summary: A retrospective review of all incisional hernia repairs at North Shore Hospital (NSH), Auckland, NZ was performed between January 2004 and July 2019. Patients who had an open or laparoscopic incisional hernia repair with mesh were included in this study. Patients were retrospectively followed up from the date of their operation until the end of the study period.


Eligibility criteria: Inclusion Criteria:

* Primary surgical procedure was incisional hernia repair with mesh

Exclusion Criteria:

* Suture repair
* Other hernia repair (not incisional)
* Operation notes unavailable

Primary outcomes:
measure: Post operative complications
timeFrame: 30-days post procedure
measure: Length of Hospital Stay
timeFrame: 0 days - 38 days
Secondary outcomes:
measure: Recurrence of hernia
timeFrame: 0 days - 15 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04213339: Effectiveness of Kegal Exercises on Urinary Incontinence Impact in Geriatric Incontinence
Official title: Effectiveness of Kegal Exercises on Urinary Incontinence Impact in Geriatric Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence in Geriatric Population
Lead sponsor: Zohra Institute of Health Sciences
Sponsor class: OTHER
First posted: 2019-12-30
Enrollment: 50
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This research study was used to determine effectiveness of kegal exercise on urinary incontinence impact in geriatric incontinence. There were two groups, One group was experimental which was subjected to Kegel exercises while other was control group without any treatment.


Eligibility criteria: Inclusion Criteria:

* Patient 50 years of age and above.
* Geriatric population
* Male participant

Exclusion Criteria:

* Patient below 50 years of age.
* Patient with neurological problem.
* Uncooperative attitude
* Male patients with prostate problem \& Female participants

Primary outcomes:
measure: Incontinence Impact
timeFrame: 6 to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Ali Sikandar Bhutto
Study officials:
References:
Clinical trial NCT03424239: Pilot Study for Zoledronic Acid to Prevent Bone Loss After Bariatric Surgery
Official title: Pilot Study for Zoledronic Acid to Prevent High-Turnover Bone Loss After Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bariatric Surgery Candidate
Keywords: Roux-en-Y gastric bypass, sleeve gastrectomy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2018-02-06
Enrollment: 6
Sex: ALL
Minimum age (years): 25
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All of the participants will receive zoledronic acid, as well as supplementation with calcium and vitamin D.
Primary purpose: PREVENTION

Brief summary: This study evaluates whether zoledronic acid can prevent the high bone turnover that occurs after Roux-en-Y Gastric Bypass (RYGB) and sleeve gastrectomy (SG) surgery.

Detailed description: The investigators are evaluating the ability of a single dose of zoledronic acid to improve bone outcomes after RYGB or SG surgery. The investigators have previously shown that RYGB and SG have negative effects on bone density, bone microarchitecture, and that bariatric procedures potentially increase the risk of fractures. The purpose of this study is to evaluate the safety and efficacy of zoledronic acid to prevent the high-turnover bone loss that occurs in adults who have chosen to undergo RYGB or SG.

Eligibility criteria: Inclusion Criteria:

* Men must be age ≥ 50
* Women must be age ≥ 25 and postmenopausal
* Planning to receive RYGB or SG surgery

Exclusion Criteria:

* Age \< 25
* Prior bariatric surgery
* Weight ≥ 400 lbs
* Liver or renal disease
* Hypercalcemia, hypocalcemia, or hypomagnesemia
* Serum 25-hydroxyvitamin D \< 20 ng/mL
* History of bone-modifying disorders
* Use of bone-active medications
* Known sensitivity to bisphosphonates
* Extensive dental work involving extraction or dental implant within the past 2 months or planned in the upcoming 6 months

Primary outcomes:
measure: Change in Serum CTX
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change in Total Hip Bone Mineral Density by DXA
timeFrame: Baseline and 6 months
measure: Change in Trabecular Spine Bone Mineral Density by QCT
timeFrame: Baseline and 6 months
measure: Number of Participants With Treatment-related Hypocalcemia Events as Assessed by CTCAE v4.0
timeFrame: 6 months
measure: Change From Baseline of Femoral Neck Bone Density Measured by DXA
timeFrame: Baseline and 6 months
measure: Change From Baseline of Spine Bone Density Measured by DXA
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Elaine W Yu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01864239: The Medicines Advice Service Evaluation
Official title: The Medicines Advice Service: A Randomised Controlled Trial of a Pharmacy-based Telephone Intervention to Support Patients Taking Medication for a Long-term Condition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Hyperlipidemias
Keywords: Adherence
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: Pharmacy2U
First posted: 2013-05-29
Enrollment: 677
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to find out whether talking to a pharmacist on the telephone can help to support people taking medicine for a long-term condition.

Detailed description: Non-adherence to medication is common and although some interventions have shown promise in improving adherence, the findings are inconsistent. This randomised controlled trial aims to test the effectiveness of a pharmacy-based telephone intervention compared to usual care on medication adherence and health outcomes in patients taking medicines for a long-term condition.

Eligibility criteria: Inclusion Criteria:

* Patients prescribed medication(s) for at least one of the following conditions: type 2 diabetes, hyperlipidemia

Exclusion Criteria:

* Patients living outside of England
* Patients with no access to a telephone
* Patients under the age of 18
* Patients unable to give written informed consent
* Patients on drugs for dementia
* Patients showing signs of dementia or cognitive impairment in conversation
* Patients with substantial hearing or sight impairment
* Patients whose medications are ordered by a caregiver/family member
* Patients with insufficient English to take part in the telephone intervention
* Patients living with someone already taking part in the study
* Patients newly prescribed a medication for the conditions listed in the inclusion criteria

Primary outcomes:
measure: Self-reported medication adherence
timeFrame: 6 months
Secondary outcomes:
measure: Prescription refill adherence
timeFrame: Baseline, 6 months and 12 months
measure: Self-reported medicine-related problems and concerns
timeFrame: Baseline, 3 months and 6 months
measure: Beliefs about Medicines
timeFrame: Baseline, 3 months and 6 months
measure: HbA1c
timeFrame: Baseline and 6 months
measure: Serum Cholesterol Levels
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: UCL School of Pharmacy
Study officials:
affiliation: UCL School of Pharmacy
name: Nick Barber
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lyons I, Barber N, Raynor DK, Wei L. The Medicines Advice Service Evaluation (MASE): a randomised controlled trial of a pharmacist-led telephone based intervention designed to improve medication adherence. BMJ Qual Saf. 2016 Oct;25(10):759-69. doi: 10.1136/bmjqs-2015-004670. Epub 2016 Jan 11.
Clinical trial NCT00889239: Clinical Performance and Wear Mechanism of Hot-Pressed Ceramic Crowns
Official title: Clinical Performance and Wear Mechanism of Hot-Pressed Ceramic Crowns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ceramic and Dental Enamel Wear
Keywords: ceramic
wear rate
opposing enamel
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: Thailand Research Fund
First posted: 2009-04-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objectives of this study are to characterize the clinical performance and wear mechanisms of all-ceramic posterior crowns. The wear rate of all-ceramic crowns and opposing enamel in selected patients will be quantified. The relationship of each subject's maximum clenching force and wear rate will also be analyzed.

Detailed description: High strength ceramics have been used in dentistry for constructing fixed partial denture. Their advantages are their acceptable fracture resistance, excellent biocompatibility, moderate opacity, etc. Because the increase in demand for more esthetic restoration, various ceramic materials have been used as a core material for several all-ceramic systems. Their properties have been investigated extensively in many in vitro studies. Currently, there are not much results regarding clinical performance and wear mechanism of ceramic-based prosthesis and more information are required for future research.

Eligibility criteria: Inclusion Criteria:

* Occlusion: At least 20 remaining teeth for each patient, and at least one posterior endodontically treated tooth with natural opposing teeth
* Bruxism: No evidence based on an intraoral examination
* Dental history: No evidence of either moderate or severe periodontal disease
* Medical history: Good to excellent general health

Exclusion Criteria:

* Periodontal status: Pocket depth greater than 4 mm
* Occlusion:

  * Evidence of bruxism or excessive biting or clenching force
  * Abutment tooth that opposes a removable partial denture
  * Abutment tooth for fixed partial dentures
  * Gingival recession of an abutment tooth more than 1 mm from the cementoenamel junction
  * Tooth with first or second degree of tooth mobility
  * Tooth with extensive carious lesions

Primary outcomes:
measure: Clinical performance
timeFrame: 5 years
Secondary outcomes:
measure: wear rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Dentistry, Mahidol University
Study officials:
affiliation: Mahidol University
name: Kallaya Suputtamongkol
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05822739: Safety and Efficacy Study of Parkinson's Disease Gene Therapy Drug (BBM-P002)
Official title: A Single-arm, Open-label, Single-center Trial, Evaluating the Safety and Efficacy of BBM-P002 for Primary Advanced Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease
Gene therapy
Adeno-Associated Virus
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2023-04-21
Enrollment: 6
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Safety and Efficacy Study of BBM-P002 in subjects with primary advanced Parkinson's disease

Detailed description: Parkinson's disease is a neurodegenerative disorder involving loss of dopaminergic neurons in the substantia nigra. This study is a single-center, single-arm, open-label, treatment clinical study to evaluate the safety, tolerability and efficacy of an adeno-associated virus (AAV)-based gene therapy, termed BBM-P002, will be injected into the brain via a neurosurgical procedure.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed with idiopathic Parkinson's disease.
2. Males and females, 40 to 70 years of age (inclusive).
3. Disease duration from diagnosis of ≥5 years. Responsiveness to dopamine.
4. Good compliance and regular follow-up. Completion of Parkinson's disease patient diary accurately during follow-up, and family members, guardians or caregivers can help subjects fill in patient diary.

Exclusion Criteria:

1. Atypical or secondary parkinsonism.
2. History of coagulopathy, abnormal bleeding or hemopathy family history. Other bleeding risk which increases risk of surgery determined by investigator.
3. Any type of prior gene therapy.
4. Clinically significant electrocardiogram (ECG) abnormalities.
5. Concomitant disease including unstable cardiovascular and cerebrovascular diseases within 3 months, uncontrolled hypertension, sever postural hypotension, poorly controlled diabetes, history of malignancy.
6. Acute or chronic: hepatitis B (HBV); hepatitis C (HCV) infection must have completed curative antiviral treatment with HBV/HCV viral load below the limit of quantification or be negative due to prior treatment or natural resolution to be eligible for enrollment. Subject with Human Immunodeficiency Virus (HIV) or Syphilitic serum positive should be excluded.

Primary outcomes:
measure: Incidence of Adverse Events and Serious Adverse Events
timeFrame: Day 1 through week 52
measure: Post-treatment MRI assessment
timeFrame: Day 1 through week 52
Secondary outcomes:
measure: Efficacy of BBM-P002
timeFrame: Change from Baseline to Week 52
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
Study officials:
affiliation: Xiangya Hospital of Central South University
name: Lu Shen, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06701539: Liposomal Bupivacaine for Postoperative Pain After Craniotomy
Official title: Effect of Nerve Block With Liposome Bupivacaine for Postoperative Pain After Craniotomy: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Liposome Bupivacaine
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2024-11-22
Enrollment: 106
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: Acute postoperative pain is a common postoperative adverse reaction. It refers to acute pain that occurs immediately after surgery and usually lasts no longer than 3-7. Among the craniotomy approaches, patients undergoing supratentorial craniotomy with temporal approach had a higher incidence of moderate to severe pain within 24 hours. In the management of postoperative acute pain, multimodal analgesia is recommended. Liposomal bupivacaine was encapsulated by liposomal vesicles and released slowly, lasting up to 72 hours. The long action time also makes the time window of postoperative acute pain completely covered, thus helping patients better control pain. At present, there is an obvious lack of clinical studies on the effectiveness and specific duration of liposome bupivacaine for postoperative acute pain, especially in neurosurgical craniotomy population with transtemporal incision approach, which is a high-risk group for postoperative pain in neurosurgery.


Eligibility criteria: Inclusion Criteria:

* Age 18-65 years old;
* Patients undergoing craniotomy tumor resection via frontotemporal approach, temporal base approach or temporal occipital approach;
* ASA grade I \~ III;
* Sign informed consent.

Exclusion Criteria:

* Previous history of combined drug allergy;
* Patients with a history of severe chronic pain;
* Long-term history of analgesic drug use;
* Patients with aphasia and other inability to cooperate with the scale were evaluated;
* Patients with mental system diseases;
* Patients with incomplete function of vital organs (heart, lung, liver, kidney);
* History of drug and drug abuse;
* BMI≥35kg/m2;
* Pregnant or lactating patients.

Primary outcomes:
measure: Time of first incision pain within 72 hours after surgery
timeFrame: 72 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: