louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04821180: Psychological Health Influences the Choice of Device in Proximal Humeral Fractures
Official title: Angle Stable Plate Versus Reverse Shoulder Treatment for Proximal Humeral Fractures: Should the Psychological Health Influence the Choice of Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Humeral Fracture, Proximal
Keywords: Open reduction and fixation
Reverse shoulder arthroplasty
Lead sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Sponsor class: OTHER
First posted: 2021-03-29
Enrollment: 63
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects affected by proximal humeral fractures

Brief summary: It was conducted a prospective study with a series of 63 patients treated with O.R.I.F. (Open Reduction and Internal Fixation) (group A) and with RSA (Reverse Shoulder Arthroplasty) (group B) for three and four-part proximal humeral fractures according to Neer classification system. One independent observer performed clinical and a psychological evaluation at one(T0), six(T1) and twelve months(T2) postoperatively.

The Constant's score and The Disabilities of the Arm, Shoulder and Hand (DASH score) were used for clinical evaluation, while General Anxiety Disorder-7 (GAD-7) and Caregiver Strain Scale (CSS) were used for psychological evaluation.


Eligibility criteria: Inclusion Criteria:

* Three and four-part proximal humeral fractures according to Neer classification system;
* Patients seventy years or older;
* Shoulder surgery within one week after trauma

Exclusion Criteria:

* Exposed fractures;
* Pathological fractures;
* Proximal humerus fractures with metaphyseal or diaphyseal extension;
* Contraindications to surgery associated with organ dysfunctions or with coagulopathy;
* Allergy or hypersensitivity to the orthopedic implants;
* Patients who were unable to attend the different follow-ups;
* Patients with psychiatric disorders

Primary outcomes:
measure: Change in Constant's score
timeFrame: T0 (one-month), T1 (six months), T2 (one year) post operatively
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03753880: Hemopatch for Prevention of Bile Leaks After Liver Resection
Official title: Efficacy of NHS-PEG (Pentaerythirol Polyethylene Glycol Ether Tetra-succinimidyl Glutarate) Coated Collagen Patch (Hemopatch®) for Prevention of Bile Leaks After Liver Resection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bile Leak
Keywords: Liver resection
Bile leaks
Outcome
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: In liver surgery bile leaks are still a major cause of postoperative morbidity with the need for additional diagnostic tests, additional interventions, prolonged hospital stay, mortality and higher costs. Efforts to further reduce the rate of postoperative biliary morbidity are therefore important.A new polyethylene glycol (PEG)-coated collagen pad (Hemopatch®) showed faster and more sustained hemostasis, less blood loss, and lower hematoma formation than the fibrin-coated collagen patch in an animal model. This might be attributed to an improved tissue adherence of the PEG-coated pad. We hypothesize that this strong adherence to the hepatic resection surface may also serve as a mechanical sealant of bile ducts thus preventing biliary leakage.

To date, there exists no study including a sufficient number of patients to clarify whether sealing of the hepatic resection surface with Hemopatch® can reduce the rate of biliary leaks and data regarding the expected difference in the incidence of biliary complications are lacking.


Eligibility criteria: Inclusion Criteria:

* Elective hepatic resection

Exclusion Criteria:

* Minor atypical hepatectomy without a plain cut surface
* Contraindications to the application of Hemopatch®

Primary outcomes:
measure: Bile leaks
timeFrame: 30 days
Secondary outcomes:
measure: Bleeding
timeFrame: 30 days
measure: Abscess
timeFrame: 30 days
measure: Mortalitiy
timeFrame: 30 days
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna
Study officials:
References:
Clinical trial NCT05971680: the Effect of Vitamin B 1 on Menstrual Pattern After Insertion of the IUD.
Official title: the Effect of Vitamin B 1 on Menstrual Pattern After Insertion of the IUD.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Intra-uterine Device Complication
Keywords: Intra-uterine Device
Vitamin B 1
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: investigate the effect of vitamin B 1 on menstrual bleeding and spotting after insertion of the IUD.

Detailed description: This study will be randomized controlled trial will be performed at the Obstetric and Gynecological Department at Beni-Suef University Hospital, Faculty of Medicine Target Population: All females with first time use of IUD inserted at the Obstetrics and Gynecology department through 3 months from the start of July 2023 till the end of November 2023.

Participants will be assigned in a 1:1 ratio to the use of vitamin B 1 or placebo, in accordance with a random table produced by an Excel program, with A being assigned to the intervention group and B to the control group. All women will sign a written informed consent prior to data collection.

Each woman within the intervention group will receive a packet containing 30 pills (vitamin B 1 or placebo), each month for three months.

Eligibility criteria: Inclusion Criteria:

* Females with first time use of the IUD
* a history of normal menstrual bleeding with duration of 3 to 7 days without spotting, a menstrual cycle lasting 23 to 35 days,
* use of 10 to 14 sanitary pads per cycle before IUD insertion
* gravidity ranging between 1 and 4.

Exclusion Criteria:

* Patients with cardiac, hepatic or renal diseases.
* Patients with bleeding disorders.
* Patients with systemic diseases.

Primary outcomes:
measure: the duration of menstrual bleeding.
timeFrame: 3 cycles ( 3 months / one month for each cycle)
Secondary outcomes:
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni-suef university Hospital
state: Beni Suef
Study officials:
References:
Clinical trial NCT04507880: A 2-Year Prospective Follow-up Study of the Global Unite Reverse Fracture Shoulder System for Proximal Humerus Fractures
Official title: A 2-Year Prospective Follow-up Study of the Global Unite Reverse Fracture Shoulder System for Proximal Humerus Fractures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Shoulder Fractures
Keywords: Humeral Fractures, Proximal
Lead sponsor: Herlev and Gentofte Hospital
Sponsor class: OTHER
Collaborators: name: Herlev and Gentofte Hospital
First posted: 2020-08-11
Enrollment: 42
Sex: ALL
Minimum age (years): 65
Maximum age (years): 120
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluated the efficacy and safety of the reverse total shoulder prosthesis (RTSA) for complex proximal humerus fractures. The clinical results of RTSA will be compared to clinical results from a historical cohort, that received a hemiarthroplasty of the shoulder.


Eligibility criteria: Inclusion Criteria:

* Fracture or fracture dislocation not suitable for non-operative treatment or for osteosynthesis due to displacement and comminution
* Patients older than 65-years of age, or younger than 65-year of age if the surgeon assesses the physiological age as older.
* All patients, regardless of age, with an insufficient or irreparable rotator cuff

Exclusion Criteria:

* Brachial plexus palsy
* Previous ipsilateral fracture of clavicula, scapula, or proximal humerus
* Cognitive disabilities or substance abuse enabling rehabilitation and follow-up
* Patients without a Danish civil registration number

Primary outcomes:
measure: Change in Constant score (CS)
timeFrame: The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery
Secondary outcomes:
measure: Change in Oxford Shoulder Score (OSS)
timeFrame: The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery
measure: Change in Western Ontario Osteoarthritis of the Shoulder Index (WOOS)
timeFrame: The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery
measure: Change in EQ5D questionnaire
timeFrame: The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery
measure: Change in Numeric Ranking Scale
timeFrame: The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery
measure: Complications
timeFrame: The outcome is registered 2 years after surgery
measure: Change in humeral tuberosities
timeFrame: The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Herlev and Gentofte Hospital
name: Bo S Olsen, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT04705480: Pregabalin vs. Gabapentin on Reducing Opioid Usage
Official title: Pregabalin vs. Gabapentin on Reducing Opioid Usage in Trauma Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Analgesics
Gabapentin
Injuries
Narcotics
Pain
Trauma
Keywords: Pregabalin , ,
Gabapentin
Opioid Pain Medication Use
Trauma
Opioid Usage Reduction
Lead sponsor: CAMC Health System
Sponsor class: OTHER
First posted: 2021-01-12
Enrollment: 210
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: This is a single-center, randomized, open-label, Phase 4 clinical trial investigating the efficacy of multiple-dose administrations of Pregabalin or Gabapentin in combination with traditional opioid pain medications to decrease the amount of opioid pain medication usage in single-system orthopedic trauma patients.


Eligibility criteria: Inclusion Criteria:

1. Nurse Practitioner service admissions
2. 18 years of age or older
3. Patients enrolled within 36 hours of admission
4. Anticipated duration of hospitalization \> 24 hours from time of consent
5. Active order(s) for opioids in place at the time of enrollment

Exclusion Criteria:

1. Clinician discretion based on patient care management
2. Intubated patients
3. Patients with epidural
4. Patients with pregabalin/gabapentin as home medications
5. Patients receiving pregabalin/gabapentin upon admission
6. Traumatic brain injury patients
7. CrCl\<30ml/min or on HD
8. Unable to take enteral medications
9. On Patient Controlled Analgesia (PCA)
10. Patients with complicated wound closure
11. History of epilepsy
12. Documented history of substance use disorder

Primary outcomes:
measure: Reduction in opioid usage
timeFrame: First 7 days post-enrollment or until discharge, if discharge < 7 days post-enrollment
Secondary outcomes:
measure: Incentive spirometry values
timeFrame: First 7 days post-enrollment or until discharge, if discharge < 7 days post-enrollment
measure: Rate of intubation
timeFrame: First 7 days post-enrollment or until discharge, if discharge < 7 days post-enrollment
measure: Pain control
timeFrame: First 7 days post-enrolment or until discharge, if discharge < 7 days post-enrollment
measure: Hospital length of stay
timeFrame: First 7 days post-enrollment or until discharge, if discharge < 7 days post-enrollment
measure: Rate of unplanned ICU admission
timeFrame: First 7 days post-enrollment or until discharge, if discharge < 7 days post-enrollment
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Charleston Area Medical Center"s Level 1 Trauma Center
state: West Virginia
Study officials:
References:
Clinical trial NCT01283880: Renal Tubular Acidosis in Incident Renal Transplant Recipients
Official title: Renal Tubular Acidosis in Incident Renal Transplant Recipients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Renal Transplant Disorder
Keywords: kidney
transplantation
metabolic acidosis
renal tubular acidosis
nephrocalcinosis
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2011-01-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: renal transplant recipients

Brief summary: Metabolic acidosis is a common complication in incident renal transplant recipients. Protracted acidosis may be associated with osteoporosis, inflammation, negative protein balance and malnutrition, and last but not least may cause renal dysfunction. Preliminary data indicate an increased prevalence of nephrocalcinosis in renal transplant biopsies of incident patients presenting with metabolic acidosis. The present study aims (1)evaluate the prevalence and type of renal tubular acidosis (RTA) in incident renal transplant recipients and to identify clinical correlates and (2) to find associations between RTA, nephrolithiasis and nephrocalcinosis


Eligibility criteria: Inclusion Criteria:

* Recipient of a single kidney transplant included in the protocol biopsy program.
* eGFR \> 30 ml/min
* Age ≥ 18 years
* Written informed consent

Exclusion Criteria:

* none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Pieter Evenepoel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03236480: The Gut-lung Axis in Chronic Obstructive Pulmonary Disease
Official title: Dynamic Changes of the Respiratory Microbiota and Its Relationship to Fecal Microbiota in Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Disease, Chronic Obstructive
Microbiota
Immunity, Mucosal
Metabolism
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Ningde City Hospital, Fujian, China
First posted: 2017-08-02
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to Peking University People's Hospital and Ningde City Hospital with an exacerbation of COPD between January 2017 and January 2019 will be enrolled.

Brief summary: Patients with chronic obstructive pulmonary disease (COPD) are 2-3 times more likely to occur together with chronic gastrointestinal tract (GIT) diseases, such as inflammatory bowel disease (IBD) or irritable bowel syndrome (IBS). Similarly, despite many patients have no history of acute or chronic respiratory disease, up to 50% of IBD patients and 33% of IBS patients have pulmonary involvement, such as inflammation or impaired lung function. Increasing evidence indicated chronic gut and lung disease share key conceptual features with the disorder and dysregulation of the microbial ecosystem. However, the underlying mechanisms are not well understood.

Our study is aimed to elucidate the intimate relationship between the gastrointestinal tract and respiratory tract, and uncover the mechanisms by which the gut microbiota affects the immune responses in the lungs, and vice versa.


Eligibility criteria: Inclusion Criteria:

* admitted to hospital with an exacerbation of COPD;
* with no history of probiotics taken;
* the duration of antibiotics treatment before enrollment should be less than 72 hours.

Exclusion Criteria:

* being immunocompromised, including history of glucocorticoid taken for more than 1 month, history of immunosuppressive therapy, history of human immunodeficiency virus (HIV) infection, solid tumor or hematological malignancy;
* history of long-term nursing home stays;
* history of recently hospitalized (\<90 days).

Primary outcomes:
measure: all-cause mortality
timeFrame: patients will be followed for 3 months after their remission from hospital
Secondary outcomes:
measure: exacerbations
timeFrame: during the 3-month follow-up
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Zhancheng Gao, Pro.
role: STUDY_CHAIR
References:
citation: Xie Y, Xue Q, Jiao W, Wu J, Yu Y, Zhao L, Xu Y, Deng X, Fang G, Zheng Y, Gao Z. Associations Between Sputum Torque Teno Virus Load and Lung Function and Disease Severity in Patients With Chronic Obstructive Pulmonary Disease. Front Med (Lausanne). 2021 Apr 22;8:618757. doi: 10.3389/fmed.2021.618757. eCollection 2021.
Clinical trial NCT06613880: Standard Immunosuppressive Therapy Combined With Romiplostim N01 as First-line Treatment for Severe Aplastic Anemia
Official title: A Prospective, Single Center, Single-arm Study on the Efficacy and Safety of Standard Immunosuppressive Therapy Combined With Romiplostim N01 as First-line Treatment for Severe Aplastic Anemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Aplastic Anemia
TPO Receptor Agonists
Keywords: Severe aplastic anemia
Romiplostim N01
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
Collaborators: name: Qilu Pharmaceutical Co., Ltd.
First posted: 2024-09-26
Enrollment: 48
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This prospective, single center, single-arm study aims to evaluate the efficacy and safety of anti-human T lymphocyte porcine immunoglobulin (p-ALG) in combination with cyclosporine and Romiplostim in treating severe aplastic anemia (SAA). It will include 48 patients with newly diagnosed SAA.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 12 years
* Diagnosis of severe or very severe aplastic anemia
* Patients are unconditionally or unacceptable undergoing allogeneic hematopoietic stem cell transplantation
* ECOG performance status ≤2
* Willing and able to comply with the requirements for this study and written informed consent.

Exclusion Criteria:

* Received \> 4 weeks of TPO-RA drug before treatment
* Received \> 4 weeks of immunosuppressive therapy before treatment
* History of thromboembolic disease
* Intolerance to Romiplostim N01 or cyclosporine
* Allergy to ALG
* Presence of uncontrolled active infection
* Presence of uncontrolled hypertension (≥140/90mmHg), diabetes mellitus (fasting blood glucose≥ 7.0 mmol/L or random blood glucose ≥ 11.1 mmol/L)
* Abnormal liver and kidney function: Aspartate Transaminase (AST) or Alanine Transaminase (ALT) \> 3 ULN, creatinine ≥ 2.5 ULN
* History of chemoradiotherapy for malignant solid tumors
* History of other systemic serious illnesses
* Females who are pregnant/lactating or need pregnancy
* Patients considered to be ineligible for the study by the investigator for reasons other than the above

Primary outcomes:
measure: Overall response rate
timeFrame: Within 27 weeks post treatment
Secondary outcomes:
measure: Overall response rate
timeFrame: Within 3 months post treatment
measure: Time to hematological response
timeFrame: Within 27 weeks post treatment
measure: Incidence of adverse events
timeFrame: Within 27 weeks post treatment
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Regenerative Medicine Center and Red Blood Cell Disorders Center
state: Tianjin
Study officials:
affiliation: Institute of Hematology & Blood Diseases Hospital, China
name: Jun Shi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06011980: Life-2023-02 Esophagogastric Variceal Bleeding
Official title: Life-2023-02 Study on the Efficacy of Growth Inhibitors After Endoscopic Treatment of Acute Esophagogastric Variceal Bleeding
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Esophageal Variceal Hemorrhage
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 33
Sex: ALL
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: Study on the efficacy of the growth inhibitors after endoscopic treatment of acute esophagogastric variceal bleeding

Detailed description: Participants with acute esophagogastric variceal bleeding in 5 days and under stable status will be included in this study. All the patients will take CTP test to confirm the blood flow status of the portal vein before endoscopic treatment. After that they will be randomly divided into two groups: A. accept growth inhibitors after the endoscopic treatment for 5 days; B. no growth inhibitor will be applied after the treatment.

Eligibility criteria: Inclusion Criteria:

* acute esophagogastric bleeding with hepatic cirhosis;
* stable status (no active bleeding)

Exclusion Criteria:

* endoscopic test limitation;
* previous acute esophagogastric bleeding treatment history;
* ICU;
* pregnant;
* Immunity disabled;

Primary outcomes:
measure: rebleeding rate after the endoscopic treatment in Group A at 1 month
timeFrame: 1 month after the endoscopic treatment
measure: rebleeding rate after the endoscopic treatment in Group A at 3 months
timeFrame: 3 months after the endoscopic treatment
measure: rebleeding rate after the endoscopic treatment in Group A at 6 months
timeFrame: 6 months after the endoscopic treatment
measure: rebleeding rate after the endoscopic treatment in Group B at 1 month
timeFrame: 1 month after the endoscopic treatment
measure: rebleeding rate after the endoscopic treatment in Group B at 3 months
timeFrame: 3 months after the endoscopic treatment
measure: rebleeding rate after the endoscopic treatment in Group B at 6 months
timeFrame: 6 months after the endoscopic treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Hanzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References: