louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04723992: 25-Year Experience With Polytraumatized Patients in a Level 1 Trauma Center
Official title: 25-Year Experience With Polytraumatized Patients in a Level 1 Trauma Center.: Polytrauma Between 1995 and 2019: What Has Changed
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polytrauma
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Retrospective analysis of polytrauma patients.

Brief summary: In this study patients who were admitted to our hospital with critical injuries were enrolled retrospectively from January 1992 to December 2019. Patients with an ISS\>16 points, an AIS \>3 in one body region and at least 2 different body regions affected were included. Possible prognostic factors were evaluated.


Eligibility criteria: Inclusion Criteria:

* ISS \>16 points
* AIS \>3 in one body region
* at least 2 body regions affected

Exclusion Criteria:

* patients younger than 18 years of age
* isolated traumatic brain injury
* minor injuries (AIS \<3 or ISS \<16 points)

Primary outcomes:
measure: In-hospital mortality in polytrauma patients.
timeFrame: January 1st 1992 to December 31st 2019
measure: Possible prognostic factors influencing the outcome of polytrauma patients.
timeFrame: January 1st 1992 to December 31st 2019
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Department of Traumatology
Study officials:
References:
citation: Weihs V, Frenzel S, Dedeyan M, Hruska F, Staats K, Hajdu S, Negrin LL, Aldrian S. 25-Year experience with adult polytraumatized patients in a European level 1 trauma center: polytrauma between 1995 and 2019. What has changed? A retrospective cohort study. Arch Orthop Trauma Surg. 2023 May;143(5):2409-2415. doi: 10.1007/s00402-022-04433-1. Epub 2022 Apr 12.
Clinical trial NCT00795392: Preoperative Psychological Evaluation as Predictor of Outcomes
Official title: Preoperative Psychological Evaluation as Predictor of Post-surgical Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Elective Surgery
Keywords: Psychology
Postoperative outcome
Surgical Operation
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2008-11-21
Enrollment: 200
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: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All types of patients undergoing surgical operations

Brief summary: Perioperative psychological care is increasingly recognized as an essential part in the surgical environment. Previous studies have developed a strategy to evaluate the psychological influence after operations and found that postoperative psychological states significantly associated with the outcomes of patients. However, preoperative evaluation of patients the physicians do thus far is mainly the physical status assessment following the scale of American Society of Anesthesiologists (ASA). Whether a full-scale evaluation of preoperative psychological status to surgical patients could be a predictor to postoperative outcomes or not is not still completely understood. The investigators hypothesized that the preoperative psychological assessment would be an important predictor to outcomes.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective surgical operation
* Age from 18-65 years

Exclusion Criteria:

* Age \<18 years or \>65 years
* Not willing to participate in this study
* Patients from emergency department

Primary outcomes:
measure: Time of recovery
timeFrame: Since the end of the operation (1 day) to six-month follow-up.
Secondary outcomes:
measure: Intraoperative consumption of drugs
timeFrame: From the time of start of operation (0 min) to the end of the surgical procedures, this time will undergo alteration in different individuals
measure: Hospitalization days
timeFrame: Time length of staying at hospital from the day of inpatient to discharge home, this time will undergo alteration in different individuals
measure: Life quality
timeFrame: Since the end of the operation (1 day) to six-month follow-up.
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Maternal and Child Health Care Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing Medical University
name: XiaoFeng Shen, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01390792: Special Drug Use Investigation for Relenza® (Zanamivir) (Prophylaxis)
Official title: Special Drug Use Investigation for Relenza® (Zanamivir) (Prophylaxis)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza, Human
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-07-11
Enrollment: 622
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: \<Zanamivir prophylactic administration group\> Subjects meeting all of the following criteria and starting prophylactic administration of zanamivir

* family or persons living with patients with influenza virus infection
* subjects meeting any of the following criteria, elderly subjects ( 65 years old and over), subjects with chronic cardiac disease, with metabolic disease (diabetes, etc.) or with renal dysfunction
* unvaccinated persons during the applicable seasons
* subjects whose consent to write influenza diary was obtained

\<Non-zanamivir prophylactic administration group\>

- subjects meeting all of the above criteria and NOT starting prophylactic administration of zanamivir

Brief summary: The purpose of this post-marketing surveillance study is to collect information on efficacy and safety for prophylactic administration of zanamivir in clinical practice in family or persons living with patients with influenza virus infection.


Eligibility criteria: Inclusion Criteria:

* Subjects who meet the study population criteria

Exclusion Criteria:

* Subjects with a history of hypersensitivity to the ingredients of zanamivir

Primary outcomes:
measure: The number of incidence of adverse events in subjects treated with zanamivir
timeFrame: 11 days
measure: Occurrence of influenza virus infection
timeFrame: 11 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Keizo Matsumoto, Hideyuki Okano, Naomi Hasegawa, Ichiro Ohwaki, Shogo Inoshiri. Study on Preventive Effects of Zanamivir (Relenza) for Influenza. Medicine and Drug Journal. 2010;46(11):121-132.
Clinical trial NCT06688292: The Safety and Effectiveness of Taneasy and Actein in COPD Patients
Official title: A Randomized, Safety and Efficacy Study of Taneasy 600mg Granules and Actein Effervescent Tablets 600MG in COPD Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: COPD (Chronic Obstructive Pulmonary Disease)
Lead sponsor: Bun Yao Biotechnology Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: KGS Pharmamate Co., Ltd
name: Taichung Veterans General Hospital, Taichung
First posted: 2024-11-14
Enrollment: 42
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of Taneasy 600mg granules and Actein effervescent tablets 600MG administered twice daily for 14 days in treatment of COPD Disease.

Detailed description: The study will enroll 40\~60 patients and complete 40 patients.

Eligibility criteria: Inclusion Criteria:

1. Subjects aged older than 20\~75 years old.
2. Able to sign informed consent prior to the study.
3. Subjects have COPD.

Exclusion Criteria:

1. Subjects with known hypersensitivity to Acetylcysteine preparations.
2. Subjects with other serious medical diseases that are judged by the attending physician to affect the evaluation results (such as: tuberculosis, pneumonia, bronchial asthma, bronchiectasis, cor pulmonale, lung cancer, acute myocardial infarction, acute hepatitis, renal failure, etc.)
3. Pregnancy or breast-feeding woman.
4. Female subjects or their sexual partners do not use contraception during the trial.
5. Joining any drug clinical trial within 3 months prior to dosing.
6. Investigator considered to be inappropriate for enrollment.
7. Phenylketonuria (PKU).

Primary outcomes:
measure: To evaluate the safety and efficacy of Taneasy 600mg granules and Actein effervescent tablets 600MG administered twice daily for 14 days in treatment of COPD Disease.
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
References:
Clinical trial NCT03637192: Acute Exposure of High Altitude on Cognitive Function
Official title: Acute Exposure to Hypoxia in Precapillary Pulmonary Hypertension: Physiological and Clinical Effects at Rest and During Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Hypertension
Keywords: High Altitude
cognitive function
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2018-08-17
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Including a baseline assessment and assessments at Low altitude and High altitude
Primary purpose: PREVENTION

Brief summary: Randomized crossover Trial in patients with pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary Hypertension (CTEPH) to assess the acute response to High Altitude (2500m above sea level) on cognitive functions

Detailed description: Low altitude baseline measurements will be performed in Zurich (460m) including Echocardiography, Right heart catheterization, 6 Minute walk test, pulmonary function test, clinical assessment and blood gas analysis.

Randomly assigned to the order of testing, the participants will be tested in Low Altitude (Zurich, 470m) and at High Altitude (2500m).

During the exposure to High Altitude (Säntis; 2500m above sea level) for approximately 5 hour, the participants will perform cognitive function test .

The results will be compared to low altitude in Zurich (470m).

Eligibility criteria: Inclusion Criteria:

* Informed consent
* PH diagnosed according to internation Guidelines: mPAP ≥ 25 mmHg along with a PAWP ≤15 mmHg during right heart catheterization at the time of Initial diagnosis
* PH class 1 (PAH) or 4 (CTEPH)
* Stable condition, on the same medication for \> 4 weeks
* Patient live permanently at an altitude \< 1000m asl.

Exclusion Criteria:

* Resting PaO2 ≤7.3 kPA corresponding to the requirement of long-term oxygen therapy \> 16hour daily (nocturnal oxygen therapy alone is allowed)
* Severe daytime hypercapnia (pCO2 \> 6.5 kPa)
* Susceptibility to high altitude related diseases (AMS, HAPE, etc.) based on previous experienced discomfort at altitudes.
* Exposure to an altitude \>1500m for ≥3 nights during the last 4 weeks before the study participation
* Residence \> 1000m above sea level
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurological or orthopedic problems with Walking disability
* Women who are pregnant or breast feeding

Primary outcomes:
measure: Cognitive Function test
timeFrame: 1 day at altitude
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Respiratory Clinic, University Hospital of Zurich
Study officials:
affiliation: University of Zurich
name: Silvia Ulrich, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06021392: Comparative Study Between Wide Local Excision and Minimal Excision of Pilonidal Sinus
Official title: Comparative Study Between Wide Local Excision and Minimal Excision of Pilonidal Sinus
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pilonidal Sinus
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-09-01
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy people of both genders with or without history of PNS procedures before

Brief summary: Comparative study between wide local excision and minimal excision of pilonidal sinus

Detailed description: Pilonidal sinus (PNS) disease is distributed in young adults who are supposed to be healthy with maximum productivity. Wide local excision creates a tissue gap, while the concept of minimal excision preserves healthy tissues with minimal tissue gap.

Pilonidal disease is a frequent suppurative condition that occurs twice as often in men as in women, usually between the ages of 15 and 30. Pilonidal disease is located beneath the skin of the sacro-coccygeal region. It presents acutely as an abscess under tension while the chronic form gives rise to intermittent discharge from pilonidal sinus(es). Diagnosis is clinical and usually straightforward. In the large majority of cases, treatment is surgical but there is no consensus as to the 'ideal' technique. Acute abscess must be evacuated and an off-midline incision seems preferable. Excision is the standard definitive treatment but the choice of wide versus limited excision on the school of thought. Minimal excision or debridement of the sinus and/or cavity through a midline or a separate paramedian excision can also be performed, leaving the wounds open or closed. These methods are simple and cost-efficient, and associated with low pain, rapid healing, and a rapid return to normal activity. A disadvantage is the higher recurrence rate; however, these methods can be used repeatedly for recurrences. Although recurrence rates seem high at first glance, the procedures can be successfully repeated for recurrences, achieving healing rates of over 90% for 1-2 interventions. Future well-designed trials are necessary to aid patient selection.

Eligibility criteria: Inclusion Criteria:

* Patients complaining of primary PNS and Recurrent PNS following Minimal excision

Exclusion Criteria:

* Recurrent PNS following wide local excision

Primary outcomes:
measure: Rate of recurrence
timeFrame: In about 6 month follow up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00734292: Single-dose Crossover Study to Evaluate the Early Bronchodilating Effect of FlutiForm HFA pMDI in Adult Subjects With Mild to Moderate Asthma
Official title: A Randomized, Placebo-controlled, Double-blind, Crossover, Single-dose Exposure Study to Evaluate the Early Bronchodilating Effect of FlutiForm 100/10 µg HFA pMDI and FlutiForm 250/10 µg HFA pMDI, Compared to Placebo in Adult Subjects With Mild to Moderate Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mild to Moderate Asthma
Keywords: Asthma
Asthma Mild to Moderate
Lead sponsor: SkyePharma AG
Sponsor class: INDUSTRY
Collaborators: name: Abbott
First posted: 2008-08-14
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The primary purpose of this study is to evaluate the early bronchodilating effect of SKP FlutiForm HFA pMDI compared to placebo.


Eligibility criteria: Inclusion Criteria:

* Subjects with documented history of mild to moderate asthma currently taking a stable dose of inhaled corticosteroid

Exclusion Criteria:

* Participation in a prior FlutiForm study
* Smoking history within the last 12 months,
* Significant, non-reversible, pulmonary disease
* Life-threatening asthma within the last year

Primary outcomes:
measure: Change from baseline FEV1 to post study drug dosing FEV1
timeFrame: 3 minutes
Secondary outcomes:
measure: Change from baseline FEV1 to post study drug dosing FEV1
timeFrame: 8, 15, 30, and 60 minutes
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Investigational Site
state: California
city: Mission Viejo
country: United States
facility: Investigational Site
state: California
city: Denver
country: United States
facility: Investigational Site
state: Colorado
city: Valrico
country: United States
facility: Investigational Site
state: Florida
city: Medford
country: United States
facility: Investigational Site
state: Oregon
city: Portland
country: United States
facility: Investigational Site
state: Oregon
city: Richmond
country: United States
facility: Investigational Site
state: Virginia
city: West Allis
country: United States
facility: Investigational Site
state: Wisconsin
Study officials:
References:
Clinical trial NCT01896492: Clomiphene Plus N-acetyl Cysteine for Induction of Ovulation in Newly Diagnosed Pcos.
Official title: Clomiphene Citrate Plus N-acetyl Cysteine Versus Clomiphene Citrate for Induction of Ovulation in Women With Newly Diagnosed Polycystic Ovary Syndrome: a Randomized Double-blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: PCOS
Keywords: PCOS,
NAC,
OVULATION INDUCTION,
CLOMOPHEN CITRATE
Lead sponsor: Woman's Health University Hospital, Egypt
Sponsor class: OTHER
First posted: 2013-07-11
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders, affecting approximately 6-10% of women of reproductive age. Anovulation, infertility and hyperandrogenism often co-exist with hyperinsulinaemia and insulin resistance .

Clomiphene citrate remains the standard drug for induction or augmentation of ovulation. However, it is not equally effective in all situations, and therefore it may require additional expensive drugs such as N-acetyl cysteine, as an antioxidant, has been suggested as an adjuvant in clomiphene-resistant cases .NAC may also improve the circulating level of insulin and insulin sensitivity in hyperinsulinaemic women with PCOS, and may be useful for the treatment of insulin resistance by ameliorating the homocysteine and lipid profile in PCOS .

Detailed description: NAC has been used effectively as an adjuvant to clomiphene citrate (CC) for ovulation induction in CC-resistant women with PCOS .

Because it is an insulin sensitizer, NAC was proposed as an adjuvant to clomiphene citrate for ovulation induction in patients with polycystic ovary syndrome who are resistant to clomiphene citrate. Encouraging results in those patients stimulated us to investigate whether adding NAC to the standard treatment with CC results in a higher ovulation rate, higher pregnancy rate, and less CC resistance in women with newly diagnosed polycystic ovary syndrome using a randomized, double-blind, controlled study.

Eligibility criteria: Inclusion Criteria:

* PCOS diagnosed by Rotterdam's criteria

Exclusion Criteria:

* previous induction of ovulation male factoe infertility tubal factor infertility uterine factor infertility

Primary outcomes:
measure: Ovulation rate
timeFrame: 2 years
Secondary outcomes:
measure: include PR, number of follicles of ≥ 18 mm, the serum E2 concentration, serum P, and endometrial thickness
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Woman's Health University Hospital, Egypt
name: Alaa M Ismail, M D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03644992: An Analysis Into the Cause and Preventional Method of Thromboembolic Disease in Gynecological Surgery
Official title: An Analysis Into the Cause and Preventional Method of Thromboembolic Disease in Gynecological Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thromboembolic Disease
Gynecological Surgery
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2018-08-24
Enrollment: 54
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The planned sample size was based on data from a previous study, in which the standard deviation was 5. We assumed an one-tailed α error of 0.05 and a sampling error of 1.0. we propose to enroll 60 participants and allow for a dropout rate of 10% for an effective sample size of 54.

Brief summary: The aim of this cross-sectional study is to describe the specific situations of thromboembolic disease in gynecological surgery and identify the risk factors of it.

Detailed description: The electronic medical data of 54 patients who undergo operations to treat gynecological diseases but develop thromboembolic disease will be analyzed retrospectively in this study. The location, symptom and other situations of embolism will be described and multiple linear analyse will be employed to identify the risk factors of it.

Eligibility criteria: Inclusion Criteria:

1. Volunteer to participate in the study with informed consent;
2. Females aged 20-80 who are confirmed with some gynecological diseases and are treated with surgery but embolism happens unfortunately.

Exclusion Criteria:

1. Pregnancy, lactation, postmenopause, or planned pregnancy within two years;
2. Patients with blood diseases prone to thrombosis and those with a history of thrombus were excluded;
3. History of hyperparathyroidism, infectious diseases (tuberculosis, AIDS), autoimmune diseases, or digestive system diseases (malabsorption, crohn disease and dysentery);
4. Other diseases or heavy injuries that will interfere with the results;
5. Simultaneous participation in another clinical study with investigational medicinal product(s) or researcher thinks the subjects are not suitable for this trial.

Primary outcomes:
measure: the percentage of different symptoms of thromboembolic disease(%)
timeFrame: 10 months after the operation
Secondary outcomes:
measure: the location of embolism
timeFrame: 10 months after the operation
measure: the risk factors of thromboembolic disease
timeFrame: 10 months after the operation
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: TING LI
state: Zhejiang
Study officials:
References: