louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00092729: An Investigational Drug Study in the Treatment of Primary Dysmenorrhea (0663-064)
Official title: A Randomized, Placebo-and Active-Comparator-Controlled Study of Etoricoxib 120 mg in the Treatment of Primary Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dysmenorrhea
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2004-09-28
Enrollment: 129
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the pain relieving effect and safety of an investigational drug in women with moderate to severe primary dysmenorrhea (painful menstruation).


Eligibility criteria: Inclusion Criteria:

* Women 18 years of age or older suffering from painful menstruation

Exclusion Criteria:

* Women taking medications that are not allowed in the study (such as pain medications, antidepressants, tranquilizers, hypnotics, sedatives, or oral contraceptives).
* Women who are pregnant, breast-feeding or within 6 weeks of giving birth

Primary outcomes:
measure: Overall analgesic effect as measured by the total pain relief score over 8 hours post dose (TOPAR8), sum of pain intensity difference over 8 hours post dose (SPID8), and patient's global evaluation at 8 and 24 hours post dose compared with placebo
timeFrame: Up to 8 hours postdose and at 8 and 24 hours postdose, following onset of moderate-to-severe pain due to primary dysmenorrhea for each of three consecutive menstrual cycles
measure: Time to onset, peak, and duration of the analgesic effect compared with placebo
timeFrame: to 24 hours following onset of moderate-to-severe pain due to primary dysmenorrhea for each of three consecutive menstrual cycles
Secondary outcomes:
measure: Overall analgesic effect, time to onset, peak, and duration of analgesic effect compared with naproxen sodium
timeFrame: Up to 24 hours following onset of moderate-to-severe pain due to primary dysmenorrhea for each of three consecutive menstrual cycles
measure: Overall analgesic effect, time to onset, peak, and duration of analgesic effect of naproxen sodium compared with placebo
timeFrame: Up to 24 hours following onset of moderate-to-severe pain due to primary dysmenorrhea for each of three consecutive menstrual cycles
measure: Safety and tolerability of etoricoxib as assessed by the number of patients with clinical or laboratory adverse experiences
timeFrame: From randomization through 14 days following the last dose of study medication
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01907529: A Trail of Neoadjuvant Endostar in Combination With Chemotherapy in Breast Cancer
Official title: A Trail of Neoadjuvant Endostar in Combination With Docetaxel, Epirubicin and Cyclophosphamide in Patients With Stage III Breast Cancer (TENDENCY)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Stage III Breast Cancer
Lead sponsor: Hebei Medical University Fourth Hospital
Sponsor class: OTHER
First posted: 2013-07-25
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The trial was designed to study the efficacy and safety of neoadjuvant docetaxel, epirubicin in combination with cyclophosphamide(DEC) plus human recombinant endostatin (endostar) for breast cancer patients. The hypothesis of this protocol is that the combined an active angiogenesis agent to chemotherapy could enhance the pathological responce rate and further benefit breast cancer patients.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed invasive breast cancer (core needle biopsy for breast cancer diagnosis and fine needle aspiration for lymph node metastasis diagnosis)
* Age 18-70
* No evidence of distant metastasis
* No previous therapy
* Normal hematologic function
* No abnormality of renal or liver function
* Written informed consent

Exclusion Criteria:

* With allergic constitution or possible allergic reflection to drugs to be used in this study
* Any concurrent uncontrolled medical or psychiatric disorder
* History of severe heart diseases, including congestive heart failure, unstable angina, uncontrolled arrhythmia, myocardial infarction, uncontrolled high blood pressure, or heart valve disease
* Being pregnant or nursing

Primary outcomes:
measure: Clinical/pathological response
timeFrame: 48 months
Secondary outcomes:
measure: PFS
timeFrame: 5 years
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: Fourth Hospital of Hebei Medical University, Tumor Hospital of Hebei Province, China
state: Hebei
Study officials:
affiliation: Hebei Medical University Fourth Hospital
name: YUNJIANG LIU, M.D.& PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03146429: Prediction of Future Weight Change With Dopamine Transporter
Official title: Prediction of Future Weight Change With Dopamine Transporter
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Weight Change, Body
Lead sponsor: Pusan National University Hospital
Sponsor class: OTHER
First posted: 2017-05-10
Enrollment: 200
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consisted of 192 healthy controls with screening 123I-FP-CIT SPECT.

Brief summary: This is the re-analyzing study of observational study by Parkinson's Progression Markers Initiative


Eligibility criteria: Inclusion Criteria:

* males or females with their age of 30 years or older at screening

Exclusion Criteria:

* subjects with a neurological disorder, a first degree relative with idiopathic PD, Montreal Cognitive Assessment score of 26 or less, medications that might interfere with DAT SPECT scans, anticoagulants that might preclude safe completion of the lumbar puncture, or investigational drugs, and a condition that precludes the safe performance of routine lumbar puncture

Primary outcomes:
measure: Weight change
timeFrame: 1, 2, 3, 4, 5 year after SPECT
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03600129: Qudratus Lumborum Block for Postoperative Pain After Endoscopic Prostatectomy.
Official title: Ultrasound-guided Quadratus Lumborum Block for Postoperative Pain Control After Endoscopic Prostatectomy - Double Blinded, Placebo-controlled, Randomised Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: regional anesthesia
quadratus lumborum block
patient controlled anesthesia
laparoscopic prostatectomy
Lead sponsor: Centre of Postgraduate Medical Education
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 50
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind, placebo-controlled, randomised
Primary purpose: SUPPORTIVE_CARE

Brief summary: Laparoscopic prostatectomy (LP) is characterized by substantial tissue trauma, despite its minimally -invasive approach. Although postoperative pain intensity is lower when compared to open procedures, the use of opioids is common. Retrospective review of available LP cases revealed that although analgesic demand varied, nearly all of our LP patients required opioids postoperatively. Bilateral Quadratus Lumborum Block (QLB), being one of relatively new features of regional anesthesia, offers good analgesia of abdominal wall, with the potential for control of visceral pain. This study was established to evaluate its effectiveness in alleviating pain after radical prostatectomy in a double - blind, placebo - controlled manner.


Eligibility criteria: Inclusion Criteria:

* ASA status less or equal 3
* Scheduled for transperitoneal or extraperitoneal endoscopic prostatectomy
* Able to understand information provided and to sign the informed consent for participation in the study

Exclusion Criteria:

* known allergy to local anesthetics and opioids
* infection in the area of block placement
* known chronic use of opioids, gabapentinoids and tricyclic antidepressants
* mental inability to understand the principles and rules of patient-controlled analgesia pump

Primary outcomes:
measure: Opioid consumption following prostatectomy
timeFrame: 24 hours
Secondary outcomes:
measure: Pain score
timeFrame: 24 hours
measure: Time to first dose of opioid
timeFrame: 24 hours
measure: Opioids - related complications
timeFrame: 24 hours
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Centre of Postgraduate Medical Education,Department of Anesthesia and Intensive Care
Study officials:
affiliation: Orlowski Hospital, Centre of Postgraduate Medical Education, Department of Anesthesiology and Intensive Care
name: Malgorzata Malec-Milewska, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03510429: Clinical Validation of Nutritional Supplements("Ketogenic Plus") Developed for Pancreaticobiliary Cancer Patients
Official title: Clinical Validation of Nutritional Supplements("Ketogenic Plus") Developed for Pancreaticobiliary Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreaticobiliary Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2018-04-27
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Decreased bowel function and loss of appetite in patients who underwent pancreaticobiliary surgery contribute impaired nutritional status in postoperative period. It can also affect perioperative and oncologic outcomes negatively. Therefore it is important to improve nutritional status in postoperative period by supply tailor-made optimal diets. The investigators have developed customized postoperative diets and products for pancreaticobiliary cancer patients. This time, newly developed ketogenic drink contain beefsteak mint.

The investigators expect that nutritional supplement for pancreaticobiliary patients will increase the food intake rate and contribute a improvement of perioperative outcomes and even oncologic outcomes.


Eligibility criteria: Inclusion Criteria:

* Adult (age more than 19)
* Pancreaticobiliary cancer patient who is scheduled pancreaticoduodenectomy or distal pancreatectomy
* Pancreatic cancer / Duodenal cancer / Distal bile duct cancer / Ampulla of Vater cancer

Exclusion Criteria:

* Patient who denied clinical trial
* Diabetes Mellitus(DM) patient with DM complication
* Hyperlipidemia patient with vascular co-morbidity
* Impaired renal function or renal failure (GFP\<70%)
* Poor nutritional status (PG-SGA grade C)

Primary outcomes:
measure: Food Intake Rate(%) for postoperative diet
timeFrame: 1 day before operation
measure: Food Intake Rate(%) for postoperative diet
timeFrame: 3 days after food intake
measure: Food Intake Rate(%) for postoperative diet
timeFrame: at the discharge date (8 weeks after operation)
measure: Food Intake Rate(%) for postoperative diet
timeFrame: at the first follow up date (4 weeks after discharge)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT04200729: Povidone-iodine Irrigation for Prevention of Intra-abdominal Abscess in Pediatric Perforated Appendicitis: a Multi-center Stepped Wedge Cluster Randomized Study
Official title: Povidone-iodine Irrigation for Prevention of Intra-abdominal Abscess in Pediatric Perforated Appendicitis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Acute, Perforated Appendicitis
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2019-12-16
Enrollment: 1750
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Stepped-wedge cluster randomized trial (SW-CRT). After a period of baseline data collection, clusters will be randomized to cross over from control to intervention in a stepwise fashion until all clusters have been exposed.
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the effect of intra-abdominal irrigation with povidone-iodine (PVI) versus usual care on the rate of 30-day postoperative intra-abdominal abscesses (IAA) and to determine the effect of PVI irrigation versus usual care on 30-day hospital length of stay(LOS) and 30-day readmissions.


Eligibility criteria: Inclusion Criteria:

* Admitted to a participating center
* Appendectomy performed for acute appendicitis
* Intraoperative diagnosis of perforated appendicitis

Exclusion Criteria:

* Simple or gangrenous appendicitis
* Interval or incidental appendectomy
* Initial attempt at non-operative management (defined as \>48 hours between the time of diagnosis and surgical intervention)
* History of iodine allergy, thyroid disease or renal dysfunction
* Pregnancy

Primary outcomes:
measure: number of patients with post operative intra-abdominal abscesses
timeFrame: 30 days post surgery
Secondary outcomes:
measure: Length of hospital stay(LOS)
timeFrame: 30 days post surgery
measure: Number of patients that are readmitted
timeFrame: 30 days post surgery
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Kuojen Tsao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04407429: Vienna Versus SARS-CoV-2 Virus Study
Official title: Vienna Versus SARS-CoV-2 Virus: A Prospective Large-scale Antibody Study of SARS-CoV-2 in Patients and Health Care Workers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SARS-CoV-2
COVID-19
Keywords: COVID-19
SARS-CoV-2
Immunity
Antibodies
Virus
Respiratory Virus
Immunoglobulins
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 12000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cohort A: Health care workers

Cohort B: Patients admitted for non-COVID related symptoms

Brief summary: This study examines the seroprevalence against SARS-CoV-2 in health care workers and patients at the Vienna General Hospital.

Detailed description: This study consists of 2 parts: a longitudinal study enrolling 3,000 health care professionals at the Vienna General Hospital testing their antibody status 6 times over a period of 12 months (Cohort A), and a serial cross-sectional study of 3,000 patients (i.e., a total of 9,000 patients) admitted to the Vienna General Hospital for non-COVID-19-related symptoms at 3 different time points during this pandemic (Cohort B).

Eligibility criteria: Cohort A:

Inclusion criteria:

* Physicians
* Nursing staff
* Midwives
* Medical-technical assistants (including medical, therapeutic and diagnostic healthcare staff, and medical and nursing assistants)
* Administrative personnel with patient contact

Exclusion Criteria:

* Not employed at the Medical University of Vienna or the Vienna General Hospital
* No signed informed consent

Cohort B:

Inclusion Criteria:

● Patients with available residual serum samples

Exclusion Criteria:

● Serum samples from COVID-19 triage units at the Vienna General Hospital

Primary outcomes:
measure: Prevalence of antibody status in healthcare workers and in patients admitted for non-COVID-19 related symptoms over time
timeFrame: 1 year
Secondary outcomes:
measure: Incidence rate of sero-conversion
timeFrame: 1 year
measure: Identification of risk markers/factors for SARS-CoV-2 infection
timeFrame: 1 year
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Christian Hengstenberg, Univ.-Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06964529: Evaluation of the Effects of I-PRF and C-PRF on Gingival Phenotype
Official title: Evaluation of the Effects of I-PRF and C-PRF on Gingival Phenotype
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gingival Phenotype
Periodontal Soft Tissue
Width of Keratinized Gingiva
Keywords: C-PRF
I-PRF
VISTA Technique
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2025-05-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm parallel design comparing the effects of I-PRF and C-PRF on gingival phenotype using VISTA technique.
Primary purpose: TREATMENT

Brief summary: This clinical trial aims to evaluate the effects of injectable platelet-rich fibrin (I-PRF) and concentrated platelet-rich fibrin (C-PRF) on gingival phenotype in patients undergoing mucogingival surgery with the VISTA technique. Changes in gingival thickness and width of keratinized gingiva will be assessed using both manual and digital methods.

Detailed description: The study is designed as a randomized controlled clinical trial including 30 patients, divided into two groups: I-PRF and C-PRF. All participants receive a mucogingival procedure using the VISTA technique followed by four sessions of PRF injections (one during surgery and three at 10-day intervals). The primary outcomes are changes in gingival thickness and the width of keratinized gingiva, measured manually and digitally at baseline, 1 month, and 3 months. The aim is to compare the effectiveness of I-PRF and C-PRF on soft tissue enhancement.

Eligibility criteria: Inclusion Criteria:

Systemically healthy individuals aged 18-65 years No periodontal surgery in the last 6 monthsClinically healthy periodontium (no signs of active periodontal disease) Patient compliance and consent to participate

Exclusion Criteria:

Smoking Pregnancy or lactation Systemic diseases affecting healing (e.g., diabetes, immunosuppression) Use of anticoagulants or medications affecting soft tissue Poor oral hygiene or noncompliance

Primary outcomes:
measure: Change in gingival thickness
timeFrame: Baseline, 1 month, 3 months
Secondary outcomes:
measure: Change in width of keratinized gingiva
timeFrame: Baseline, 1 month, 3 months
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Inonu University Faculty of Dentistry
Study officials:
References:
Clinical trial NCT01325129: Elastic Stable Intramedullary Nailing of Dislocated Clavicle Fractures in Children
Official title: Elastic Stable Intramedullary Nailing of Dislocated Clavicle Fractures in Children and Adolescents: Lessons Learned From the First 20 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dislocated Clavicular Fracture Treated With Elastic Stable Intramedullary Nailing
Keywords: ESIN
Clavicular Fracture
Dislocation
Children
Adolescents
Lead sponsor: University of Luebeck
Sponsor class: OTHER
First posted: 2011-03-29
Enrollment: 20
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Last 24 Patients we Treated with ESIN

Brief summary: Most Clavicular Fractures in Children can be Treated Conservatively. Our Own Study showed a Benefit towards Much Lower Pain and Better Cosmesis in Adolescents when Treated with Elastic Stable Intramedullary Nailing.

The First 20 Patients Treated with this Method will be examined for Functional (CONSTANT and MURLEY-Score) and Cosmetic Results as well as Ultrasound-Morphology of both clavicles and Patients'satisfaction (CSS-8). Further on, all complications and problems will be documented.


Eligibility criteria: Inclusion Criteria:

* Only Dislocated Shaft Fractures or Pseudarthrosis after Conservative Treatment of Dislocated CSF in Children and Adolescents Treated with Elastic Stable Intramedullary Nailing

Exclusion Criteria:

* Age \> 17 years
* Pathologic fractures
* Lateral or Medial Fractures of the Clavicle

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Luebeck
country: Germany
facility: Department of Pediatric Surgery University Hospital
Study officials:
References:
citation: Prinz KS, Rapp M, Kraus R, Wessel LM, Kaiser MM. [Dislocated midclavicular fractures in children and adolescents: who benefits from operative treatment?]. Z Orthop Unfall. 2010 Jan;148(1):60-5. doi: 10.1055/s-0029-1186155. Epub 2009 Oct 19. German.
citation: Rapp M, Prinz K, Kaiser MM. Elastic stable intramedullary nailing for displaced pediatric clavicle midshaft fractures: a prospective study of the results and patient satisfaction in 24 children and adolescents aged 10 to 15 years. J Pediatr Orthop. 2013 Sep;33(6):608-13. doi: 10.1097/BPO.0b013e31829d1a76.