louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06529627: GDF-8 Levels in ICSI Cycles
Official title: Effect of Growth Differentiation Factor - 8 (GDF-8) on Pregnancy Rates in GnRH-agonist ICSI Cycles: A Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2024-07-31
Enrollment: 42
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group of infertile couple undergoing ICSI-ET with the standard long GnRH agonist protocol
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the role of GDF-8 in regulating progesterone levels during controlled ovarian stimulation in patients undergoing ICSI-ET and to evaluate its effects on pregnancy rates.

The main questions are

* Does serum GDF-8 correlate with serum Progesterone levels during ovarian stimulation?
* Does serum GDF-8 serum level at different time-points during ovarian stimulation correlate with pregnancy rate?

participants will undergo ICSI-ET cycle using the long GnRH-agonist protocol and serum levels of GDF-8 and progesterone will be measured at three time-points during the trial: on day of hCG trigger administration, on day of oocyte pickup, and 14 days after embryo transfer


Eligibility criteria: Inclusion Criteria:

* The study population included women who underwent their first ICSI-ET cycles due to male and/or tubal factors or unexplained infertility, aged 20-35 years, whose BMI ranged from 19-29.9 kg/m2, with regular menstrual cycles

Exclusion Criteria:

* women with PCOS, couples with azoospermic husbands, women with poor ovarian reserve testing (AMH \< 1.2 ng/dl and/or AFC \< 5), women diagnosed with endometriosis, and women with medical comorbidities such as thyroid disorders, DM, hyperprolactinemia, etc.

Primary outcomes:
measure: Clinical pregnancy
timeFrame: 5 weeks after embryo transfer
measure: Serum Growth Differentiation Factor - 8 (GDF-8)
timeFrame: three time-points: on day of trigger, on day of OPU, and 14 days after ET
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Shatby maternity university hospital
Study officials:
References:
Clinical trial NCT02729727: Clinical Study to Evaluate CryoBalloon™ Ablation System in Patients Undergoing Esophagectomy
Official title: Clinical Study to Evaluate the CryoBalloon™ Full Ablation System for the Ablation of Human Esophageal Epithelium in Patients Undergoing Esophagectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Cancer
Lead sponsor: Pentax Medical
Sponsor class: INDUSTRY
First posted: 2016-04-06
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: To evaluate the safety and treatment effect of the CryoBalloon™ Full Ablation System for the ablation of human esophageal epithelium in patients scheduled to undergo esophagectomy

Detailed description: The primary outcomes for the study are the safety and treatment effect of the CryoBalloon™ Ablation System. An esophagectomy will be performed as scheduled following the ablation procedure; histopathological analysis of surgically-resected specimens will be performed to determine the treatment effect.

Eligibility criteria: Inclusion Criteria:

* Up to two (2) areas of 3 cm each non-ulcerated, columnar lined esophagus or squamous linted tissue suitable for ablation
* Older than 18 years of age at the time of consent
* Requires a clinically-necessary esophagectomy for esophageal cancer
* Patient has provided written informed consent using the Informed Consent Form approved by the Institution's reviewing Medical Ethics Committee (MEC)

Exclusion Criteria:

* Patient refuses or is unable to provide written informed consent
* Patient has esophageal narrowing limiting access to the intended site of ablation

Primary outcomes:
measure: Safety of CryoBalloon Ablation System
timeFrame: through study completion, an average of 2 weeks
Secondary outcomes:
measure: Device Performance
timeFrame: through study completion, an average of 2 weeks
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Centre Amsterdam
state: North Holland
Study officials:
affiliation: AMC Medical Research B.V.
name: Jacques J.G.H.M. Bergman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01228227: ROsuvastatin Pretreatment to Reduce MyocArdial Periprocedural Necrosis:Comparison With Atorvastatin Reloading
Official title: High Loading ROsuvastatin Pretreatment in Patients Undergoing Elective PCI to Reduce the Incidence of MyocArdial Periprocedural Necrosis : Comparison With Atorvastatin High Dose Reloading.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Assess the Periprocedural Myocardial Necrosis
Keywords: Myonecrosis
Percutaneous Angioplasty
Myocardial Infarction
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2010-10-26
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An increase in cardiac biomarkers has been shown to occur in 5% to 30% of patients after otherwise successful percutaneous coronary interventions (PCIs)(1) Apart from side-branch occlusion, intimal dissection and coronary spasm, a possible aetiology of myonecrosis after PCI might be distal embolization of atherogenic materials from plaque disruption,(2 )causing obstruction of blood flow at capillary level resulting in micro-infarction.(3,4 )Recent studies have suggested that pretreatment with Atorvastatin may be associated with a reduction in infarct size after elective PCI. (5-7 ). Actually the standard pretreatment in patients undergoing elective coronary-PCI and already treated with aspirin is clopidogrel loading dose administration before procedure.(8,9)The investigators compared a high (80mg) re-loading dose of Atorvastatin with a high loading dose of Rosuvastatin (40 mg) both administered within 24h before the procedure in reducing the rate of periprocedural MI. Therefore, the investigators will conduct a single center, prospective randomized study to assess whether a single, high (80mg) loading (within 24h)dose of Atorvastatin compared with a single loading dose of Rosuvastatin (20 mg) is effective in preventing elevation of biomarkers of MI after elective coronary stent implantation. We evaluate the incidence of MACCE(occurring of cardiac death, myocardial infarction (including periprocedural myonecrosis) and stroke at 30 days 6 and 12 month follow-up.


Eligibility criteria: Inclusion Criteria:

Patients with stable angina

Exclusion Criteria:

Baseline myocardial enzyme rise

Primary outcomes:
measure: Myocardial enzymes arise
timeFrame: 12- 24 hours
Secondary outcomes:
measure: MACCE
timeFrame: 1-6-12 Months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Policlinico Umberto I
Study officials:
References:
Clinical trial NCT02468427: Objective Structured Assessment of Technical Skills (OSATS) Evaluation of Delivery by Vacuum Extraction
Official title: Objective Structured Assessment of Technical Skills (OSATS) Evaluation of Operative-Vaginal Delivery by Vacuum Extraction on a Pelvic Training Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2015-06-10
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: In a prospective, randomized Trial, the investigators compare Hands-on teaching and frontal teaching using a Training Video for learning how to perform an assisted delivery by vacuum extraction on a pelvic Training model. Objective Structured Assessment of Technical Skills (OSATS) scores are the primary outcome. The investigators hypothesize that Hands-on Training is superior to a video-teaching with regard to the OSATS scores achieved by the Trainees.

Detailed description: The optimal mode of Training surgical novices how to perform an assisted delivery by means of vacuum extraction is unknown. We prospectively randomize probands to a 30 min hands-on (group 1) and a 30 min demonstration (group 2) training session teaching a standardized vacuum Extraction (VE) algorithm scheme on a pelvic training model. Probands are tested with a 24 item Objective Structured Assessment of Technical Skills (OSATS) scoring system after training and 48 hours, and 72 hours thereafter. OSATS scores are the primary outcome. Performance time (PT), self assessment (SA), confidence (CON), and global rating scale (GRS) are the secondary outcomes. Statistics will beperformed using Mann-Whitney U-test, chi-square test, and multivariable logistic regression analysis.

Eligibility criteria: Inclusion Criteria:

* Medical Student
* no previous experience in assisted delivery
* no previous gynecologic surgery training

Exclusion Criteria:

* language barrier
* unwillingness to participate

Primary outcomes:
measure: OSATS scores
timeFrame: 5 min after the training
Secondary outcomes:
measure: OSATS scores after 48 hours
timeFrame: 48 hours after the training
measure: OSATS scores after 72 hours
timeFrame: 72 hours after the training
Other outcomes:
Locations:
city: Herne
country: Germany
facility: Dept. OBGYN Ruhr University Bochum
Study officials:
affiliation: Ruhr University Bochum
name: Clemens B Tempfer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hilal Z, Kumpernatz AK, Rezniczek GA, Cetin C, Tempfer-Bentz EK, Tempfer CB. A randomized comparison of video demonstration versus hands-on training of medical students for vacuum delivery using Objective Structured Assessment of Technical Skills (OSATS). Medicine (Baltimore). 2017 Mar;96(11):e6355. doi: 10.1097/MD.0000000000006355.
Clinical trial NCT04986527: Duration of Chest Tube Suction in Traumatic Pneumothorax
Official title: Chest Tube Management in Traumatic Pneumothorax: Does Duration of Suction Matter
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Traumatic Pneumothorax
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2021-08-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot study is to determine whether chest tube suction duration, 24 hours vs 48 hours, prior to water seal affects outcome and length of stay after placement for traumatic pneumothorax.


Eligibility criteria: Inclusion Criteria:

* Trauma service consult/patient
* Traumatic pneumothorax with chest tube placed within 0-24 hours of presentation and confirmation of adequate position
* Age \>18
* Blunt or penetrating mechanism
* Chest tubes sizes 14 to 32Fr
* Chest tubes placed by residents on the trauma surgery service supervised by attending trauma surgeons or placed by the attending surgeon themselves
* Presence of single chest tube in one or both pleural cavities (single unilateral or bilateral tubes)
* Subjects with decision making capacity (DMC) who are able to provide written consent. DMC will be determined by the consenting physician through a teach back mechanism. Subjects must demonstrate understanding of the situation, appreciation of the consequences of their decision, reasoning of their thought process, and be able to communicate their wishes.

Exclusion Criteria:

* Age \<18
* Pregnant patients
* Prisoners
* Mechanically ventilated in ICU for more than 24 hours while chest tube in place
* Chest tubes placed as part of, or present during, a thoracic operation
* History of surgery involving pleural cavity ipsilateral to chest tube
* Subjects with more than one chest tube on the ipsilateral side at any time prior to study chest tube removal
* Subjects with chylothorax or empyema
* Subjects with chest tubes that are withdrawn or removed unintentionally
* Subjects with known or suspected bronchial injury
* Subjects with bullous emphysema.

Primary outcomes:
measure: Chest tube dwell time
timeFrame: up to 1 month
Secondary outcomes:
measure: Number of participants with reaccumulation of pneumothorax
timeFrame: up to 3 days
measure: Number of participants with at least one pulmonary complications
timeFrame: up to 1 week
measure: Readmission to hospital
timeFrame: 30 days
measure: Transfer to ICU
timeFrame: up to 1 week
measure: Median length of stay
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References:
Clinical trial NCT01002027: Three Model Care Pathways for Postnatal Depression
Official title: Models of Care: Evaluating a Best Practice Model of Treating Postnatal Depression (PND)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postnatal Depression
Keywords: Postnatal Depression
CBT-Counselling
Primary care
Lead sponsor: University of Melbourne
Sponsor class: OTHER
Collaborators: name: Beyondblue (The National Depression Initiative)
First posted: 2009-10-27
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study evaluates three best-practice care pathways for postnatal depression (PND) by comparing sole General Practitioner (GP) management to GP management in combination with CBT-based counselling from either a Psychologist or a Maternal and Child Health Nurse (MCHN).


Eligibility criteria: Inclusion Criteria:

* English-speaking women at 3-months postpartum

Exclusion Criteria:

* Psychosis

Primary outcomes:
measure: Clinical Depression Score
timeFrame: 8 weeks post-randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Austin Health
state: Victoria
Study officials:
affiliation: University of Melbourne & Austin Health
name: Jeannette Milgrom, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Milgrom J, Holt CJ, Gemmill AW, Ericksen J, Leigh B, Buist A, Schembri C. Treating postnatal depressive symptoms in primary care: a randomised controlled trial of GP management, with and without adjunctive counselling. BMC Psychiatry. 2011 May 27;11:95. doi: 10.1186/1471-244X-11-95.
Clinical trial NCT01945827: Evaluation of DeltaMaxx® Microcoil System in Intracranial Aneurysms
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Intracranial Aneurysms
Lead sponsor: Codman & Shurtleff
Sponsor class: INDUSTRY
First posted: 2013-09-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects who have been diagnosed with a ≥ 6 mm intracranial aneurysm.

Brief summary: The primary objective of this registry is to assess the safety and angiographic outcomes of endovascular treatment of intracranial aneurysms using the DeltaMaxx Microcoil System.


Eligibility criteria: Inclusion Criteria:

* Subject age ≥18 and ≤80 with a diagnosis of ruptured or unruptured intracranial aneurysm judged suitable for selective endovascular treatment by coil occlusion during single procedure
* Investigator intends to use DeltaMaxx Microcoil system during coiling procedure
* Investigator intends to use only Codman Neuro microcoils during coiling procedure
* Aneurysm size \[largest measurement from the cross sectional images to determine overall aneurysm size, not just the lumen\] ≥6 mm
* If ruptured aneurysm: Hunt and Hess 1, 2, or 3
* If unruptured aneurysm: Subject grade Modified Rankin Scale 0 - 2
* The subject or his/her Legally Authorized Representative must voluntarily provide Informed Consent for participation in this study and agree to return for all study visits.

Exclusion Criteria:

* Prior treatment (surgical or endovascular) of the target aneurysm
* Subjects with more than one aneurysm (\>2 mm) that have been treated with endovascular or clipping techniques in the past 30 days.
* Subject with social, medical or psychological conditions that interfere with treatment and follow-up evaluation
* Women who are pregnant or plan to become pregnant during the study
* Life expectancy less than 12 months.
* Presence of arteriovenous malformation
* Fusiform, mycotic, traumatic, or tumoral aneurysms
* Planned aneurysm treatment by parent vessel occlusion
* Subject enrolled in any concurrent study

Primary outcomes:
measure: Primary Effectiveness Objective - Angiographic Outcomes
timeFrame: 12 Months
measure: Primary Safety Endpoint - Neurological Morbidity and Mortality
timeFrame: 12 months
Secondary outcomes:
measure: Packing Density
timeFrame: 24 hours
measure: Recurrence Rate
timeFrame: 12 months
measure: Re-treatment Rate
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00800527: Efficacy of Gabapentin in the Treatment of Chest Pain and Paresthesia in Patients With Sternotomy
Official title: Phase 4 Study of Efficacy of Gabapentin in the Treatment of Chest Pain and Paresthesia in Patients With Sternotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chest Pain
Paresthesia
Keywords: sternotomy
pain
paresthesia
Poststernotomy chest pain
Poststernotomy chest paresthesia
Lead sponsor: Usak State Hospital
Sponsor class: OTHER
First posted: 2008-12-02
Enrollment: 110
Sex: ALL
Minimum age (years): 15
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, the investigators aim to demonstrate the efficacy of gabapentin compared with diclofenac in the treatment of chronic non-ischemic chest pain and paresthesia of the patients with sternotomy and to elucidate the similarities of PCPP to neuropathic pain syndromes.

Detailed description: Because the primary objective of this study is to evaluate the effect of different drugs on chest pain and paresthesia, we choose the prospective, randomized, open label, blinded end point design for this study. According to this design, both patients and physicians making first assessment are aware of the treatment but the investigators making second and third assessment are blinded to treatment. Therefore, two separate cardiovascular surgeons wil select and randomize the patients and a cardiologist blinded to treatment assignments will evaluate the patients at second interview at thirty day and 3 months later. The study was approved by the Local Ethics Committee and informed consent was obtained from each patient. The study was conducted in Usak State Hospital with collaboration the Department of Cardiology of Ataturk Education and Training Hospital.

Eligibility criteria: Inclusion Criteria:

* Poststernotomy chest pain and/or paresthesia

Exclusion Criteria:

* Osteoporosis, renal function impairment (creatinine value \>1.5 mg / dl.)
* Hepatic dysfunction, peptic ulcer, chest pain with ischemic origin, pediatric cases
* Over production of scar tissue, thoracic surgery other than sternotomy -
* Redo-bypass surgery, infection, sternal dehiscence,valve surgery together with bypass

Primary outcomes:
measure: Reduction of pain or paresthesia severity
timeFrame: one month
Secondary outcomes:
measure: duration of relief of pain or paresthesia
timeFrame: three month
Other outcomes:
Locations:
city: Usak
country: Turkey
facility: Usak State Hospital
Study officials:
affiliation: Investigator
name: Ismail BIYIK, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05730127: Pain Inhibitory Effects of Other Pain Induced by Mechanical Pressure Compared to Electrical Stimulation and Cold Water.
Official title: Conditioned Pain Modulation Induced by Mechanical Stimulation: A Mechanism of Manual Therapy Analgesia - Study 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Conditioned Pain Modulation
Manual Therapy
Physiotherapy
Physical therapy
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective is to estimate the effects on pain thresholds of a painful mechanical stimulus on the upper trapezius compared to a painful electrical stimulus and a diffuse noxious stimulus using the cold water hand immersion test.

Detailed description: The mechanical stimulus produced in manual therapy (MT) techniques elicits neurophysiological responses within the peripheral and central nervous system responsible for pain inhibition. Almost all types of MT elicit a neurophysiological response that is associated with the descending pain modulation circuit. But it has not been demonstrated whether this inhibition occurs through a conditioned pain modulation mechanism induced by painful mechanical stimulation that is carried out with manual therapy techniques.

Eligibility criteria: Inclusion Criteria:

* healthy male or female between 18 and 65 years
* Free of pain and with no history of chronic pain

Exclusion Criteria:

* Pregnant or having given birth within the last year

Primary outcomes:
measure: Change from Baseline in Tibialis Anterior Pressure Pain Threshold (PPT) to immediate post-conditioning stimulus
timeFrame: At baseline and immediately after the conditioning stimulus
Secondary outcomes:
Other outcomes:
Locations:
city: Alcorcón
country: Spain
facility: Universidad Rey Juan Carlos
state: Madrid
Study officials:
affiliation: Universidad Rey Juan Carlos
name: Josué Fernández Carnero, PhD
role: PRINCIPAL_INVESTIGATOR
References: