louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04751084: Buscopan in Patients Undergoing IVF/Intracytoplasmic Sperm Injection Treatment
Official title: Use of Buscopan in Patients Undergoing IVF/Intracytoplasmic Sperm Injection Treatment With High and Low Uterine Contraction Frequency Prior to Embryo Transfer: A Prospective Double-blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: IVF
Intracytoplasmic Sperm Injection
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2021-02-11
Enrollment: 675
Sex: FEMALE
Maximum age (years): 42
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective double blinded randomized controlled trial
Primary purpose: PREVENTION

Brief summary: To determine if the use of Buscopan in patients undergoing IVF/ICSI treatment with high uterine contraction frequency prior to embryo transfer has a higher live birth rate.


Eligibility criteria: Inclusion Criteria:

- Women undergoing embryo transfer in either fresh or frozen cycles

Exclusion Criteria:

* Women aged \> 42 years old
* Women with factors which will affect uterine contractility
* congenital uterine anomaly
* acquired uterine pathology such as myoma \>5cm, adenomyosis \>5cm or endometrial polyp
* Women with presence of hydrosalpinx
* Women undergoing pre-implantation genetic test in IVF cycles
* History of allergy to misoprostol , Buscopan® or same group of drug
* Contraindication to the use of Buscopan® e.g. glaucoma, myasthenia gravis, tachycardia, megacolon
* Women who are on other smooth muscle relaxant other than Buscopan®

Primary outcomes:
measure: live birth rate
timeFrame: after 24 weeks of gestation
Secondary outcomes:
measure: implantation rate
timeFrame: 8-10 days after embryo transfer
measure: clinical pregnancy rate
timeFrame: at 6 weeks gestation
measure: multiple pregnancy rate
timeFrame: after 24 weeks of gestation
measure: miscarriage rate
timeFrame: before 24 weeks of gestation
measure: ectopic pregnancy rate
timeFrame: at 6-7 weeks of gestation
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: SZE MAN JENNIFER MAK
role: PRINCIPAL_INVESTIGATOR
affiliation: Chinese University of Hong Kong
name: NGA PING PATRICIA IP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00181584: Zoledronic Acid to Prevent Bone Loss During Androgen Deprivation Therapy for Prostate Cancer
Official title: Zoledronic Acid to Prevent Bone Loss During Androgen Deprivation Therapy for Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bone Loss
Prostate Cancer
Keywords: Androgen deprivation therapy
bone loss
prostate cancer
Zoledronic Acid
Zometa
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Dana-Farber Cancer Institute
First posted: 2005-09-16
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The primary objective of this study is to determine whether zoledronic acid (Zometa) given once annually increases bone mineral density in men receiving hormone therapy for prostate cancer.

Detailed description: * Patients will be randomized into 2 groups. At the screening visit, a bone mineral density test will be performed to determine if the patient has osteoporosis or not. Patients with osteoporosis will be treated with Zometa. Patients without osteoporosis will be randomly assigned to receive either Zometa or a placebo.
* Zometa is administered intravenously over a 15 minute prior once in this one year study.
* All patients will asked to take an over-the-counter oral calcium (500mg daily) and a daily multi-vitamin (containing 400-500 I.U of vitamin D) during the study.
* All patients will have clinic visits every 3 months for blood tests and to report any side effects they may be experiencing. At month 12, a bone mineral density test will be repeated.

Eligibility criteria: Inclusion Criteria:

* Adenocarcinoma of the prostate
* Current androgen deprivation therapy with expected duration of treatment greater than or equal to 12 months
* Corrected serum calcium \> 8.4mg/dl and \< 10.6mg/dl
* Serum creatinine \< 2.0mg/dl

Exclusion Criteria:

* History of bone metastases by bone scan
* Treatment with bisphosphonate within one year
* History of metabolic disease
* Chronic use of glucocorticoids, anticonvulsants, or suppressive doses of thyroxine within one year

Primary outcomes:
measure: To compare change in bone mineral density from baseline to one year between men treated with Zometa (zoledronic acid) and men treated with placebo.
timeFrame: 3 years
Secondary outcomes:
measure: To compare changes in biochemical markers of bone turnover between men treated with zoledronic acid and men treated with placebo
timeFrame: 3 years
measure: to assess the safety and tolerability of zoledronic acid.
timeFrame: 3 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Matthew Smith, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03340584: The Clinical Observation on Taping After Total Knee Replacement
Official title: The Effectiveness of the Nine Castle Net Format Taping After Total Knee Replacement in Early Postoperative Rehabilitation Period. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Total Knee Replacement
Keywords: Total Knee Replacement
Taping
Rehabilitation
Edema
Pain
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2017-11-13
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators will conduct a single-blind, randomized controlled trial of 100 patients with total knee replacement. Patients will be randomly assigned into a control group and an intervention group.Both groups received same rehabilitation procedures after surgery,except intervention group also received taping applications throughout all rehabilitation period.Then, the patients will be reevaluated to determine changes in lower extremity function, edema, pain,knee range of motion, and muscle strength of quadriceps femoris and hamstring.


Eligibility criteria: Inclusion Criteria:

1. soft-tissue swelling and pain after total knee replacement
2. agree to participate the study and signing of informed consent

Exclusion Criteria:

1. severe cognitive and language barriers that can not be used to evaluate patients with pain and swelling
2. failure of important organs, such as heart, lung, liver and kidney
3. deep venous thrombosis
4. thrombophlebitis
5. varicose veins (stage II-IVaccording to Marshall) and venous insufficiency (stadium 2-3 according to Widmer)
6. participants with infection in the areas close to the knee joint, or allergy to tape
7. enrollment in another clinical trial involving physical therapy or an investigational drug

Primary outcomes:
measure: Change from Baseline Knee Edema at 1 week
timeFrame: Baseline and at 1 week
Secondary outcomes:
measure: Change from Baseline Activities of Daily Living (ADL) at 1 week
timeFrame: Baseline and at 1 week
measure: Change from Baseline Knee Pain at 1 week
timeFrame: Baseline and at 1 week
measure: Change from Baseline Knee range of motion at 1 week
timeFrame: Baseline and at 1 week
measure: Change from Baseline muscle strength of quadriceps femoris and hamstring at 1 week
timeFrame: Baseline and at 1 week
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Songhe Jiang
state: Zhejiang
Study officials:
References:
Clinical trial NCT00168584: Different Doses of Vitamin A and Childhood Morbidity and Mortality
Official title: Randomised Study of the Impact of Different Doses of Vitamin A on Childhood Morbidity and Mortality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mortality
Morbidity
Keywords: Vitamin A
Mortality
Morbidity
Doses
OPV
Lead sponsor: Bandim Health Project
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 5400
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Vitamin A supplementation reduces all-cause mortality. It is therefore given with oral polio vaccine in national campaigns. However, it is not clear which dose is optimal. The two studies that have investigated the impact of different doses of vitamin A have both found that a smaller dose was better than a large dose. We therefore investigated if a smaller dose given with oral polio vaccine gives equal or better effect.

Detailed description: Vitamin A supplementation (VAS) to children above 6 months of age reduces all-cause mortality with 23 %1 to 30 % in low-income countries. WHO recommends VAS at vaccination contacts. The currently recommended doses to be administered every 3-6 months are 100,000 IU for infants between 6 and 11 months of age and 200,000 IU for children 12 months and older. There is no clear evidence that a large dose is better than a small dose, the tendency being the opposite in the two studies of different doses of VAS that have been published so far.

With the global effort to eradicate polio, national immunization days with oral polio vaccine (OPV) offer an additional opportunity to provide vitamin A. In Guinea-Bissau, a combined OPV and VAS campaign took place in November 2002. Given the uncertainty about the best dose of VAS, we aimed to examine whether the dose of vitamin A currently recommended by WHO or half this dose gives a better protection against childhood morbidity and mortality.

Eligibility criteria: Inclusion Criteria:Between 6 mo and 5 years old and thus eligible for OPV and vitamin A during national immunisation day

-

Exclusion Criteria:Children with overt signs of vitamin A deficiency will not be enrolled in the study, but treated according to the recommendations. -

Primary outcomes:
measure: Mortality
measure: Hospitalisations
measure: Morbidity
measure: Growth
Secondary outcomes:
measure: Rotavirus infection
Other outcomes:
Locations:
city: Bissau
country: Guinea-Bissau
facility: Bandim Health Project, Apartado 861
Study officials:
affiliation: Bandim Health Project
name: Peter Aaby, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05580484: Efficacy and Safety of Purified Starch for Adhesion Prevention in Colorectal Surgery
Official title: Efficacy and Safety of Purified Starch for Adhesion Prevention in Colorectal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adhesions Abdominal
Lead sponsor: Taipei Medical University Shuang Ho Hospital
Sponsor class: OTHER
First posted: 2022-10-14
Enrollment: 83
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent a second surgery after colorectal resection.

Brief summary: Intra-abdominal adhesion occurs in up to 90% of patients after abdominal surgery. Many patient will undergo a second surgery for temporary stoma closure, therefore these ostomy closure operations can give an opportunity to evaluate adhesion caused by previous operations. This study was conducted to use second surgery to investigate the anti-adhesion effect of purified starch among patients who underwent colorectal surgery.

Detailed description: Data was analyzed from the medical records of patients who underwent a second surgery after colectomy between January 2020 and April 2022. Patient were allocated to either the purified starch group and control group. Since January 2020, adhesion scores have been registered in operation note when patients undergo a second colorectal surgery. The primary outcomes in this study were adhesion severity and adhesion area. The secondary outcomes were operation time, blood loss, and postopera-tive complications.

Eligibility criteria: Inclusion Criteria:

* Patients who underwent a second surgery after colorectal resection between January 2020 and April 2022 were enrolled into this study.

Exclusion Criteria:

* Patients who underwent a second surgery less than 1 month after the first colorectal resection or who developed peritoneum carcinomatosis in the second surgery and patients younger than 20 years were excluded.

Primary outcomes:
measure: Adhesion severity
timeFrame: three to six months
measure: Adhesion area
timeFrame: three to six months
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Taipei Medical University Shuang-Ho Hospital
Study officials:
affiliation: Taipei Medical University Shuang Ho Hospital
name: Tung-Cheng Chang
role: STUDY_CHAIR
References:
Clinical trial NCT03968484: Platelet Transfusion in Sepsis Trial
Official title: Platelet Transfusion in Sepsis Trial (PlaTiSep)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Sepsis
Thrombocytopenia
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2019-05-30
Enrollment: 0
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: Platelets are important mediators of an inflammatory response and a key component of the innate immune system to defend the human body against invading pathogens. However, little evidence exists regarding the number of platelets that should be used als transfusion threshold in septic patients. In this trial platelet transfusion will be performed with either \<50000/µl or \<20000/µl as a trigger.


Eligibility criteria: Inclusion Criteria:

* Sepsis defined as alteration of SOFA score (Sepsis-related organ failure assessment score) \>2 points (Sepsis-3 definition)
* platelet count \<50.000/µl

Exclusion Criteria:

* Age less than 18 years
* patients with immune thrombocytopenia
* major bleeding in the last 72 hours or ongoing major bleeding
* patient, surrogate or physician not committed to full intensive care support
* pregnancy

Primary outcomes:
measure: Overall survival in 90 day follow-up period
timeFrame: 90 days
Secondary outcomes:
measure: all cause mortality at 6 months
timeFrame: 6 months
measure: resolution of shock
timeFrame: 5 days
measure: ICU length of stay
timeFrame: 28 days
measure: duration of mechanical ventilation support
timeFrame: 28 days
measure: renal replacement therapy
timeFrame: 28 days
measure: bleeding events
timeFrame: 28 days
measure: SOFA score
timeFrame: 28 days
measure: discharge location
timeFrame: 90 days
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital Tübingen
name: Peter Rosenberger, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01242384: Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women After Threatened Preterm Labor(PECEP-RETARD)
Official title: Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women After Threatened Preterm Labor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Preterm Birth
Lead sponsor: Maternal-Infantil Vall d´Hebron Hospital
Sponsor class: OTHER
First posted: 2010-11-17
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Placement of a vaginal pessary reduces significantly the rate of spontaneous preterm birth in pregnant women with short cervical length after an episode of threatened preterm labour.


Eligibility criteria: Inclusion Criteria:

* Minimal age of 18 years
* Episode of threatened preterm labour

Exclusion Criteria:

* Major fetal abnormalities (requiring surgery or leading to infant death or severe handicap)
* Spontaneous rupture of membranes at the time of randomization
* Cervical cerclage in situ
* Active vaginal bleeding
* Placenta previa

Sample size: 336 singleton (168 per arm) and 128 twins (64 per arm).

Primary outcomes:
measure: Spontaneous delivery before 34 completed weeks
timeFrame: Each 6 months
Secondary outcomes:
measure: Birth weight
timeFrame: Each 6 months
measure: Fetal-Neonatal Death
timeFrame: Each 6 months
measure: Neonatal morbidity
timeFrame: Each 6 months
measure: Maternal adverse effects
timeFrame: Each 6 months
measure: Preterm birth before 37 weeks or 28 weeks
timeFrame: Each 6 months
measure: Rupture of membranes before 34 weeks
timeFrame: Each 6 months
measure: Hospitalisation for threatened preterm labour
timeFrame: Each 6 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Vall d'Herbron
Study officials:
affiliation: Hospital Vall d'Hebron
name: Elena Carreras
role: STUDY_DIRECTOR
affiliation: Hospital Vall d'Hebron
name: Maria Goya
role: PRINCIPAL_INVESTIGATOR
References:
citation: Merced C, Goya M, Pratcorona L, Rodo C, Llurba E, Higueras T, Cabero L, Carreras E; PECEP-RETARD Trial Group. Cervical pessary for preventing preterm birth in twin pregnancies with maternal short cervix after an episode of threatened preterm labor: randomised controlled trial. Am J Obstet Gynecol. 2019 Jul;221(1):55.e1-55.e14. doi: 10.1016/j.ajog.2019.02.035. Epub 2019 Feb 28.
Clinical trial NCT04203784: Meropenem and Piperacillin Plasma Concentrations During CRRT
Official title: Meropenem and Piperacillin Plasma Concentrations During CRRT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Infection
Antibiotic
Renal Replacement Therapy
Hemolysis
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2019-12-18
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ICU patients

Brief summary: This observational study reports meropenem and piperacillin plasma concentrations in patients treated with either antibiotic and simultaneous continuous renal replacement therapy (CRRT).


Eligibility criteria: Inclusion Criteria:

* patients treated in the study ICU and
* simultaneous CRRT and antibiotic treatment with either meropenem or piperacillin-tazobactam.

Exclusion Criteria:

* none

Primary outcomes:
measure: Plasma antibiotic concentrations at mid and end of dosing interval
timeFrame: 1 week
measure: Plasma antibiotic concentrations at mid and end of dosing interval
timeFrame: 1 week
measure: Relationships between plasma antibiotic concentrations and CRRT dose.
timeFrame: 1 week
measure: Influence of residual diuresis on the measured plasma antibiotic concentrations.
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital Solna
Study officials:
References:
Clinical trial NCT03358784: Comparison of Hemi-shoulder Arthroplasty and PHILOS in Treating Three or Four-part Fractures of Proximal Humerus
Official title: A Multi-center Study on Comparison of Hemi-shoulder Arthroplasty and PHILOS in Treating Three or Four-part Fractures of Proximal Humerus.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Humeral Fracture, Proximal
Keywords: Humeral Fractures, Proximal
Arthroplasty, Shoulder Replacement
Bone Plates
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2017-12-02
Enrollment: 300
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with three or four part fractures of proximal humerus, who agreed to receive surgery.

Brief summary: To explore clinical effectiveness of PHILOS plate fixation and hemi-shoulder arthroplasty in treating three or four-part fractures of proximal humerus

Detailed description: From April 2015 and April 2017, patients from multi-center aged over 60 years old with three and four-part fractures of proximal humerus were treated with Proximal Humerus Internal Locking System(PHILOS) and hemi-shoulder arthroplasty in multi-center. All the patients received the same rehabilitation course. At 6 months after surgery, postoperative complications were observed, EQ-5D was used to evaluate quality of life, and ASES score was used to assess functional outcomes.

Eligibility criteria: Inclusion Criteria:

three or four part fractures of proximal humerus

Exclusion Criteria:

1. Severe comminuted fractures of proximal humerus
2. past history of injured-side shoulder surgery
3. Patients who cannot tolerate surgery

Primary outcomes:
measure: Postoperative complications
timeFrame: 6 months after surgery
Secondary outcomes:
measure: EQ-5D
timeFrame: 6 months after surgery
measure: ASES score
timeFrame: 6 months after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Peking University People's Hospital
name: Peixun Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: