louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02679469: A Single-center, Open-label, Single-dose Study Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Nalmefene 10 mg Tablets in Healthy Japanese Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alcohol Dependence
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: H. Lundbeck A/S
First posted: 2016-02-10
Enrollment: 7
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The safety, tolerability, and pharmacokinetics of nalmefene at a single oral dose of 10 mg in healthy Japanese male subjects will be evaluated.


Eligibility criteria: Inclusion Criteria:

* The subject is a Japanese male.
* The subject is able to read and understand the informed consent form (ICF).
* The subject has a body mass index (BMI) ≥ 19 kg/m2 and ≤ 25 kg/m2 at the screening visit.
* The subject has a resting pulse and heart rate (as read on the ECG) ≥ 45 bpm and ≤ 100 bpm at the screening visit.

Exclusion Criteria:

* The subject has taken any prescription drugs, over-the counter medications, vitamin supplements, or supplements containing St. John's Wort (Hypericum perforatum) within 2 weeks prior to Day 1.
* The subject has a significant history of alcohol abuse, defined as an alcohol intake greater than 21 units per week. (A unit of alcohol is defined as 250 mL of lager/beer, 100 mL of wine, or 25 mL of spirits.)
* The subject has taken any investigational products within 4 months prior to Day 1.

Primary outcomes:
measure: Measure the Maximum (Peak) Plasma Concentration of the Drug (Cmax)
timeFrame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
measure: Measure the Area Under the Concentration-time Curve From Time Zero to the Last Observable Concentration at Time t(AUCt)
timeFrame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
measure: Measure the Terminal-phase Elimination Half-life (T1/2)
timeFrame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Region
country: Japan
facility: Kyusyu
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: Jun-ichi Hashimoto, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06744946: Thoracoscopic Talc Pleurodesis Versus Bleomycin -Tranxemic Acid Mixture Injection in Chest Tube in Malignant Pleural Effusion
Official title: Comparison Between Pleurodesis by a Combination of Bleomycin and Tranxemic Acid Solution and Thoracoscopic Talc Poudrage in Malignant Pleural Effusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malignant Pleural Effusions (Mpe)- Pleurodesis
Pleurodesis
Keywords: Talc -pleurodesis-bleomycin
Lead sponsor: Alexandria University
Sponsor class: OTHER
Collaborators: name: Alexandria University
First posted: 2024-12-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: comparing between two groups of thirty patients each,the first group will include talc poudrage pleurodesis and the second include chest tube injection of a mixture of bleomycin and tranxemic acid
Primary purpose: TREATMENT

Brief summary: Comparing Two Methods to Treat Fluid Build-up in Chest for Cancer Patients:Talc Powder Surgery versus Chest Tube Medicine.

Detailed description: Closure of the space where the effusion is recurrently accumulated through talc poudrage in thoracoscopy or bleomycin - tranxemic acid solution injection in chest tube.

Eligibility criteria: Inclusion Criteria:

- 1. Adult patients (more than 18 years) with malignant pleural effusion or highly suspected exudate.

2. Fit patients for the procedure selected.

Exclusion Criteria:

1. Inability to provide informed consent for the procedure.
2. Hemodynamically unstable patients.
3. Bleeding diathesis.
4. Uncontrolled cough.
5. Hypoxic index less than 300.
6. Endobronchial obstruction.
7. Pleural thickening with trapped lung.

Primary outcomes:
measure: Dyspnea Borg Scale
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Chest Department -Faculty of Medicine
state: Azarita
Study officials:
affiliation: Alexandria University
name: mohamed sabry eltarhony, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04922346: The Relationship Between Physical Activity Level and Fear of Birth (Tokophobia) in Pregnant Women
Official title: The Relationship Between Physical Activity Level and Fear of Birth (Tokophobia) in Pregnant Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fear of Childbirth
Keywords: pregnancy
fear of childbirth
tokophobia
physical activity
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2021-06-10
Enrollment: 81
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy pregnant women

Brief summary: The aim of this study is to determine the effects of physical activity on fear of childbirth (tokophobia) in pregnant women.

Detailed description: Fear of childbirth is defined as the fear felt and experienced before, during and after birth. Fear of childbirth is an acceptable level of fear and motivates the woman to prepare for the birth. However, if the fear developed before pregnancy and/or the severity of the fear increased during pregnancy, this situation is called "Tokophobia".

Physical activity is defined as body movements that are performed by using the body's muscles and joints, require energy expenditure above the basal level, can be performed at different intensities, increase heart rate and respiration, and occur with the contraction of large muscle groups.

It has been shown in the literature that physical activity in pregnant women contributes to the health of both the mother and the infant.

Several studies have reported the benefits of physical activity and exercise in preventing many risks of pregnancy, including lowering the risks of excess weight gain, preeclampsia, gestational diabetes, gestational hypertension, prenatal depression and macrosomia, and improving psychological well-being.

Despite the reported benefits of regular physical activity in the literature, it has been reported that the level of physical activity during pregnancy is lower compared to the pre-pregnancy period.

Eligibility criteria: Inclusion Criteria:

Having difficulty in communicating in order to understand and answer the evaluation questions correctly, Being at 14-40 weeks of gestation, Pregnancies with regular perinatal control.

Exclusion Criteria:

Being chronically ill or obese Individuals with a history of orthopedic, neurological, rheumatological or cardiopulmonary disease or surgery, Having 2 or more miscarriages, Multiple pregnancy, High-risk pregnancy Continuous vaginal bleeding Pre-pregnancy Body Mass Index (BMI) less than 17.5.

Primary outcomes:
measure: Wijma Delivery Expectation/Experience Scale (W-DEQ)
timeFrame: Baseline
measure: The Pregnancy Physical Activity Questionnaire
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Maltepe
country: Turkey
facility: Marmara University
state: Istanbul
Study officials:
References:
Clinical trial NCT01550146: Single Dose of Dexamethasone in Femur Fractures
Official title: Effects of a Single Dose of Dexamethasone in Patients Undergoing Operative Fixation of Proximal Femur Fracture
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Fractured Neck of Femur
Keywords: Fractured neck of femur
Dexamethasone
Lead sponsor: Cork University Hospital
Sponsor class: OTHER
Collaborators: name: University of Bristol
First posted: 2012-03-09
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Fracture neck of femur is a common cause of hospital admission in the elderly and requires operative fixation.

Dexamethasone has the potential of inhibiting cortisol secretion. In addition, preoperative glucocorticoids improve analgesia and decrease opioid consumption with reduction in associated side effects in a variety of clinical settings.

The investigators hypothesis was that a single dose of preoperative dexamethasone enhance postoperative analgesia and attenuates the inflammatory response in patients undergoing operative fixation of fractured neck of femur, in a prospective, randomized, placebo controled trial.

Detailed description: Having obtained ethical approval and written informed consent from each, 40 patients scheduled to undergo operative fixation of fractured neck of femur will be randomized using sealed envelopes to two groups.

Patients in the Dexamethasone group receive a single dose of 0.1 mg/kg dexamethasone iv. preoperative, patients in the Placebo group receive the same amount of Normal Saline. The anaesthetic technique is standardized, salive samples, blood samples are taken and pain scores are measured on a visual analog scale postoperatively at several timepoints.

Eligibility criteria: Inclusion Criteria:

* above 65 years
* ASA I-III patients

Exclusion Criteria:

* patient refusal
* outside age range
* coagulation disorders
* depression
* Cushing syndrome
* endocrine disorders
* corticosteroid treatment in the last 4 month
* head injury or associated injuries
* Mini Mental Scores \< 25

Primary outcomes:
measure: Visual analogue pain scale at rest and on movement postoperatively
timeFrame: Postoperative in recovery, 6, 12, 24, 48, 72 hourly
Secondary outcomes:
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Cork University Hospital
Study officials:
References:
citation: Szucs S, Jessop D, Iohom G, Shorten GD. Postoperative analgesic effect, of preoperatively administered dexamethasone, after operative fixation of fractured neck of femur: randomised, double blinded controlled study. BMC Anesthesiol. 2016 Sep 22;16(1):79. doi: 10.1186/s12871-016-0247-5.
Clinical trial NCT03260946: The Use of Alternative Medicine by Palliative Care Patients
Official title: The Use of Complementary Medicine in Palliative/Supportive Care Centres in Lyon, France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Terminal Cancer
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-08-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with cancer receiving palliative or supportive care

Brief summary: Palliative care centres in Lyon, France as well as the disclosure of Complementary and Alternative Medicine and conventional healthcare use to conventional and Complementary and Alternative Medicine practitioners respectively.

These aims will be achieved through the following objectives:

1. Describe the prevalence of Complementary and Alternative Medicine practitioner and product use in the outpatient population of palliative care centres in Lyon, France
2. Describe the characteristics of Complementary and Alternative Medicine users the outpatient population of palliative care centres in Lyon, France
3. Estimate the Complementary and Alternative Medicine expenditure of the outpatient population of palliative care centres in Lyon, France
4. Describe the rates of disclosure of both Complementary and Alternative Medicine and conventional health care to health professionals by the outpatient population of palliative care centres in Lyon, France
5. Describe the reasons for disclosure or non-disclosure of both Complementary and Alternative Medicine and conventional health care to health professionals by the outpatient population of palliative care centres in Lyon, France


Eligibility criteria: Inclusion Criteria:

1. Patients accessing care from a palliative/supportive care centre in Lyon, France
2. Can read and understand French
3. Has been diagnosed with cancer

Exclusion Criteria:

1. The primary health condition for which they are attending the centre is not cancer
2. They are not able to read and understand French

Primary outcomes:
measure: Complementary medicine use
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: USP de Charmettes - Croix rouge française
city: Lyon
country: France
facility: Service E.M.S.P. Groupement Hospitalier Nord - Hôpital de la Croix-Rousse
city: Pierre-Bénite
country: France
facility: Centre de Soins Palliatifs Lyon-Sud Pavillon 1K - Centre Hospitalier Lyon-Sud
Study officials:
References:
Clinical trial NCT04651946: Cell-free DNA Methylation for Epithelial Ovarian Cancer
Official title: Cell-free DNA Methylation for the Diagnosis and Monitoring of Epithelial Ovarian Cancer: The Training and Validation Sets in China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Epithelial Ovarian Cancer
DNA Methylation
Benign Ovarian Tumor
Training Set
Validation Set
Cell-free DNA
Liquid Biopsy
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2020-12-03
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: All eligible patients accept DNA methylation testing in serum and in ovarian tissues.
Primary purpose: DIAGNOSTIC

Brief summary: Liquid biopsy is challenging for the diagnosis of epithelial ovarian cancer (EOC). In this study, we performed the methylation testing of host DNA, namely, OPCML, FODX3 and CDH13, in the peripheral serum to discover the diagnostic and supervision roles of DNA methylation in EOC patients. The study compromises two stages.

In the training set, DNA methylation testing is performed in the ovarian tissues from EOC and paired benign ovarian tumor patients. The cut-off values of methylation are produced in this stage. On the meantime, serum DNA methylation testing is also performed to reveal its accordance and accuracy compared with the results of ovarian tissues.

In the validation set, serum DNA methylation testing is performed in unselected ovarian tumor patients with definite cut-off values to validate its accuracy based on known histology of ovarian tumors.

In training and validation sets, serum DNA methylation is also performed after major surgeries for EOC as to illustrate the changes of methylation testing, therefore, reflection the supervision role of DNA methylation.


Eligibility criteria: Inclusion Criteria:

* With definite histological diagnosis of epithelial ovarian cancer and paired benign ovarian tumor in training set, and with definite histological diagnosis of ovarian tumor in validation set.
* With sufficient fresh peripheral serum and ovarian samples for DNA methylation testing before with or without after major surgeries.
* Aged 18 years or older.
* Signed an approved informed consents

Exclusion Criteria:

* Not meeting all of the inclusion criteria.

Primary outcomes:
measure: Cut-off values of targeted DNA methylation in epithelial ovarian cancer
timeFrame: Two years
Secondary outcomes:
measure: Accuracy of serum DNA methylation in epithelial ovarian cancer
timeFrame: Two years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Li
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lei Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06958146: Azithromycin for Preventing Maternal and Neonatal Infections During Labor.
Official title: Impact of Single Dose Azithromycin During Labor on Maternal and Neonatal Infections
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Maternal and Neonatal Sepsis
Intrapartum Antibiotics
Lead sponsor: Armed Forces Hospital, Pakistan
Sponsor class: OTHER
First posted: 2025-05-06
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, we want to see the role of the antibiotic, azithromycin, in preventing maternal and neonatal infections, if the drug is given intrapartum to the mother


Eligibility criteria: Inclusion Criteria:

* pregnant ladies with no risk factors for sepsis who go into spontaneous labor or induced labor

Exclusion Criteria:

* pregnant with risk factors for sepsis like maternal fever , raised WBC count, chorioamnionitis, or having. history of any adverse even with macrolides

Primary outcomes:
measure: maternal infections
timeFrame: birth to 6 weeks post partum
Secondary outcomes:
measure: neonatal infections
timeFrame: birth to 6 weeks post partum
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02831946: Suture Versus Glue (Dermabond) Closure During Cesarean Delivery
Official title: Intracuticular Sutures Versus Glue (Dermabond) for Skin Closure After Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Adhesive; Band
Suture; Complications
Keywords: skin closure
intracuticular suture
glue (dermabond)
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2016-07-13
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the effect of intracutaneous suture closure versus Glue (dermabond) closure at cesarean section (CS) on long-term cosmetic and maternal outcome.

Detailed description: Women undergoing planned CS were randomized to either intracutaneous suture closure or glue closure using a 1:1 allocation algorithm. Participants and outcome assessors were blinded to group allocation. Scar evaluation was performed after two months.

Primary outcome measures were Patient and Observer Scar Assessment Scale (POSAS) summary scores 2 months after surgery. Secondary outcome measures were, duration of surgery, and development of hematoma, seroma, surgical site infection (SSI) or wound disruption.

Data were analyzed according to the intention to treat principle.

Eligibility criteria: Inclusion Criteria:

* Pregnant women between 18 and 45 years
* Elective cesarian section

Exclusion Criteria:

* Clinical signs of infection at the time of CS
* History of keloids and a medical disorder that could affect wound healing
* Hypersensitivity to any of the suture materials used in the protocol
* Diabetes mellitus
* Disorders requiring chronic corticosteroid use or immunosuppression

Primary outcomes:
measure: Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: 2 month
Secondary outcomes:
measure: post operative complication
timeFrame: 1 month
Other outcomes:
Locations:
city: Kfar Saba,
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Meir Helsinki
name: Reut Ohana
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00989846: Biomarker in Lung Diseases
Official title: Feasibility Study on Establishing Biomarkers in Lung Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Diseases
Keywords: biomarker
lung disease
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2009-10-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute or chronic lung diseases

Brief summary: Disease related biomarkers have been established decades ago, e.g. blood glucose for diabetes diagnosis and management. Their discovery has grown dramatically during the past decade and they have the potential to lead the physician in diagnosis -especially differential diagnosis - and therapy.

However, a specific serum-biomarker in lung diseases has not been established. Aim of the current study is to to measure lung specific proteins in the serum in patients with various lung diseases and to correlate those with disease severity, lung function and other laboratory results


Eligibility criteria: Inclusion Criteria:

* age \>= 18
* acute or chronic lung disease

Exclusion Criteria:

* HIV
* lactation or gestation

Primary outcomes:
measure: Serum biomarker expression
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Thoraxklinik Heidelberg, Dept. of Pneumology and Respiratory Critical care
Study officials:
affiliation: Thoraxklinik Heidelberg, Germany
name: Michael Kreuter, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Thoraxklinik Heidelberg Germany
name: Felix JF Herth, MD
role: STUDY_DIRECTOR
References:
citation: Tzouvelekis A, Pneumatikos I, Bouros D. Serum biomarkers in acute respiratory distress syndrome an ailing prognosticator. Respir Res. 2005 Jun 22;6(1):62. doi: 10.1186/1465-9921-6-62.
citation: Tzouvelekis A, Kouliatsis G, Anevlavis S, Bouros D. Serum biomarkers in interstitial lung diseases. Respir Res. 2005 Jul 21;6(1):78. doi: 10.1186/1465-9921-6-78.
Clinical trial NCT05225246: Readmissions After Cardiac Surgical Procedures
Official title: Readmissions After Cardiac Surgical Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Surgery
Keywords: hospital readmission
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 4882
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Since January 2010, around 7,500 patients have had heart surgery, and around 2,083 of these patients have returned to the University Hospital of Basel within 30 days of discharge after heart surgery.

Brief summary: The aim of this study is to analyze the reasons for unplanned readmissions after cardiac surgery at the University Hospital Basel. Predictive factors for readmissions and the development over the last 10 years will be analyzed.


Eligibility criteria: Inclusion Criteria for readmission group:

* Patients who had heart surgery and returned unplanned to the University Hospital Basel within 30 days of leaving the hospital (outpatient or inpatient)

Inclusion Criteria for control group:

* Patients who had heart surgery and did not return unplanned to the University Hospital Basel within 30 days of leaving the hospital (outpatient or inpatient)

Exclusion Criteria:

* Patients with other initial hospitalization reasons for heart surgery without heart surgery (conservative treatments, cerclage removal, pacemaker surgery) are not included in the analysis.
* Planned readmissions to the University Hospital Basel within 30 days

Primary outcomes:
measure: Number of cardiac related readmissions compared to infections, bleedings and neurological causes
timeFrame: one time assessment at baseline
measure: Sex specific reasons for readmissions
timeFrame: one time assessment at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Cardiac Surgery Clinic
Study officials:
affiliation: University Hospital Basel, Cardiac Surgery Clinic
name: Oliver Reuthebuch, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: