louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01798875: PCOS, Therapy and Markers of Cardiovascular Risk
Official title: Effects of Different Therapies on Surrogate Markers of Cardiovascular Risk in Women With Polycystic Ovary Syndrome (PCOS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: PCOS
Keywords: pcos
metformin
oral contraception
cyproterone acetate
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
First posted: 2013-02-26
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In addition to chronic anovulation and hyperandrogenemia, polycystic ovary syndrome (PCOS) is also characterized by peripheral insulin resistance and hyperinsulinaemia, which in turn lead to the development of diabetes, hypertension, atherosclerosis and coronary heart disease. Serum markers of inflammation are being increasingly recognized as predictors of atherosclerosis and cardiovascular risk, and chronic low-grade inflammation has been recently proposed to play a role in the pathogenesis of metabolic syndrome and type 2 diabetes mellitus. Therefore, the aim of the present study is to evaluate the effects of commonly used non-pharmacologic (diet and lifestyle change) and pharmacologic (oral contraceptives, metformin, anti-androgens) treatment strategies on classical and surrogate cardiovascular risk markers in women with PCOS. The study hypothesis is that some of the commonly used therapies of women with PCOS may have more favorable effects on classical and surrogate markers of cardiovascular risk then others or some of them may even confer a higher risk of cardiovascular events


Eligibility criteria: Inclusion Criteria:

* PCOS

Exclusion Criteria:

* diabetes
* pregnancy
* contraindications to oral contraceptives

Primary outcomes:
measure: serum C-reactive protein (CRP) levels
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gdansk
country: Poland
facility: Department of Clinical and Experimental Endocrinology, Medical University of Gdansk
Study officials:
References:
citation: Dardzinska JA, Rachon D, Kuligowska-Jakubowska M, Aleksandrowicz-Wrona E, Ploszynski A, Wyrzykowski B, Lysiak-Szydlowska W. Effects of metformin or an oral contraceptive containing cyproterone acetate on serum c-reactive protein, interleukin-6 and soluble vascular cell adhesion molecule-1 concentrations in women with polycystic ovary syndrome. Exp Clin Endocrinol Diabetes. 2014 Feb;122(2):118-25. doi: 10.1055/s-0033-1363261. Epub 2014 Feb 19.
Clinical trial NCT05450575: An Observational Study to Evaluate Effectiveness and Safety of Amosartan Q Tablet
Official title: A Prospective, Observational Study of Factors Affecting Blood Pressure and Blood Lipids After Treatment With Amosartan Q Tablet in Hypertension Patients With Dyslipidemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Dyslipidemia
Keywords: Amosartan
Hypertension
Dyslipidemia
Observational
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2022-07-08
Enrollment: 5400
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have hypertension and dyslipidemia

Brief summary: This study was to evaluate the therapeutic effect and safety of amosartan Q tablet administration in adult patients with hypertension and dyslipidemia.

During the routine medical visit, Amosartan Q tablets were administered to patients in need of blood pressure/LDL-C control according to the investigator's judgment. In this study, effectiveness and safety information of treatment of Amosartan Q tablets was followed for 6 months (up to 12 months), and observation of the target patients was terminated after collecting relevant data.

As this study was a non-interventional observational study, all patients received prescriptions according to the routine treatment procedure, and there were no visits or procedures required according to the observational study protocol.

Detailed description: This study was a multicenter, prospective, non-interventional, observational study of factors affecting blood pressure and blood lipids after treatment with Amosartan Q tablet in hypertension patients with dyslipidemia.

Data was collected from patients receiving routine treatment at hospitals in South Korea. Each patient visited the institution according to the protocol that designed the follow-up visits for six months to examine the effectiveness and safety of Amosartan Q tablet.

This study approved by the institutions' IRBs and was conducted in compliance with clinical research ethics regulations.

Eligibility criteria: Inclusion Criteria:

* Patients with hypertension and dyslipidemia
* Those who have already decided to administer Amosartan Q tablet under the medical judgment of the researcher
* Those who voluntarily decided to participate in this study and consented in writing to the consent form

Exclusion Criteria:

* Patients for whom use of Amosartan Q tablet is prohibited

Primary outcomes:
measure: percentage(%) of patients who achieved target blood pressure
timeFrame: 6 months
measure: percentage(%) of patients who achieved target LDL-C
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanmi Pharmaceutical Company Limited
Study officials:
References:
Clinical trial NCT04517175: Could Ki-67 be Used as a Diagnostic or Prognostic Marker in Hemato-oncological Diagnostics?
Official title: Could Ki-67 be Used as a Diagnostic or Prognostic Marker in Hemato-oncological Diagnostics?
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Myelodysplastic Syndromes
Acute Myeloid Leukemia
Myelodysplastic Syndrome/Neoplasm
Keywords: Ki-67
Lead sponsor: Maastricht University
Sponsor class: OTHER
Collaborators: name: Zuyderland Medisch Centrum
name: Maastricht University Medical Center
First posted: 2020-08-18
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients in which a hemato-oncological malignancy is found and are at least 18 years old. These patients can be male and female.

Brief summary: Ki-67 is used as a marker for determination of the proliferative activity in solid tumors. The use within hemato-oncological malignancies is limited. This is related to limited technical possibilities of flow cytometry in the past. Meanwhile, flow cytometry in hemato-oncological malignancies has progressed to assessment of 8 colors and makes it possible to add Ki-67 as an additional marker to the 8-color panels. Adding Ki-67 to these panels could lead to improved diagnosis and prediction of therapy response for a number of hemato-oncological malignancies.


Eligibility criteria: Inclusion Criteria:

* MDS and AML patients

Exclusion Criteria:

* Ongoing radio- and/or chemotherapy

Primary outcomes:
measure: Maturation patterns diagnosis
timeFrame: 5 years
measure: Proliferative index diagnosis
timeFrame: 5 years
measure: Proliferative index prognosis
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Nies KPH, Kraaijvanger R, Lindelauf KHK, Drent RJMR, Rutten RMJ, Ramaekers FCS, Leers MPG. Determination of the proliferative fractions in differentiating hematopoietic cell lineages of normal bone marrow. Cytometry A. 2018 Nov;93(11):1097-1105. doi: 10.1002/cyto.a.23564. Epub 2018 Sep 3.
Clinical trial NCT02244775: Use of Avanta Metacarpophalangeal (MCP) Joint Implant Finger Prosthesis, Humanitarian Use Device
Official title: Use of Avanta Metacarpophalangeal (MCP) Joint Implant Finger Prosthesis, Humanitarian Use Device
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Arthroplasty of the MCP Joint
Keywords: osteo-arthritis
post traumatic arthritis
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2014-09-19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of this study is to allow patients to undergo surgery with the SR™ MCP (Metacarpophalangeal) Implants for finger arthritis. This is NOT a research study, but rather, a requirement by the FDA for humanitarian use of device.

Detailed description: The purpose of this IRB approved study is to allow patients to undergo surgery with the SR™ MCP (Metacarpophalangeal) Implants. This is NOT a research study, but rather, a requirement by the FDA for humanitarian use of device. Use of the SR™ MCP is approved for humanitarian use by the FDA when either the patient is in need of a revision of failed MCP prothesis(es) or the patient expects to place his/her hand under loading situation which preclude the use of an alternative implant in the painful osteo-arthritic and post traumatic arthritic MCP joint.

Eligibility criteria: Inclusion Criteria:

* patient is in need of a revision of failed MCP prosthesis(es)
* patient expects to place his/her hands under loading situations which preclude the use of an alternative implant in the painful osteo-arthritic and post traumatic arthritic MCP joint

Exclusion Criteria:

* patient is not in need of a revision of a failed MCP prothesis(es)
* patient is eligible to use an alternative implant

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
References:
Clinical trial NCT02209675: Role of Tissue C4d in Differentiation Between Acut e Rejection and HCV Recurrence After Liver Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Disease
Keywords: hepatitis C recurrence
Rejection
Liver Transplantation
Liver biopsy
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2014-08-06
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Assessment of the role of tissue C4d complement fragments in liver biopsy as a new marker for differentiating between acute rejection and Hepatitis C (HCV) recurrence in recipients post living donor liver transplantation (LDLT) .As each condition require different treatment

Detailed description: Role of tissue c4d assessment by immunohistchemistry in liver biopsy in differentiation between recurrent hepatitis c and rejection after liver transplantation.pathological examination may be sometimes confusing between the rejection and recurrent hepatitis C

Eligibility criteria: Inclusion Criteria:

* Patients transplanted for HCV related disease that are presented with elevated liver enzyme and/or hyperbilirubinemia and normal Abdominal Doppler ultrasound and Magnetic resonance cholangiography (MRCP).

Exclusion Criteria:

* Evidence of other causes of elevated liver enzyme and/or hyperbilirubinemia as abnormal Abdominal Doppler ultrasound and/or Magnetic resonance cholangiography MRCP findings.

Primary outcomes:
measure: Number of participants who developed Acute cellular rejection after transplantation
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams center for organ transplant (ASCOT)
Study officials:
References:
Clinical trial NCT02642575: Automated Folliculometry Using Five-Dimensional Ultrasound
Official title: Automated Folliculometry Using Five-Dimensional Ultrasound
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Automated Folliculometry Using Five-Dimensional Ultrasound
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2015-12-30
Enrollment: 67
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a Prospective pilot study that will be performed at the Fetal Care Unit at Ain Shams University Maternity Hospital.

67 women will be recruited from the the Fetal Care Unit who will fulfill the inclusion criteria. They will be counseled to be included into the study.

Brief summary: The aim of the study to evaluate Five-Dimensional Ultrasound in automated measurement of ovarian follicles with controlled ovarian stimulation in contrast to the conventional 2D ultrasound

Detailed description: This is a Prospective pilot study that will be performed at the Fetal Care Unit at Ain Shams University Maternity Hospital.

72 women will be recruited from the the Fetal Care Unit who will fulfill the inclusion criteria. They will be counseled to be included into the study.

All cases will be subjected to:

full history taking including patient's age, parity,last menstrual period , past history of medical disorders, clinical examinations (General and abdominal).

Two-Dimensional Ultrasound and Five-Dimensional Ultrasound will be done for all cases for assessment of ovarian follicles after controlled ovarian stimulation by clomid 50 mg5×2×1 The automated software allows for automated three-dimensional follicular measurement.The software then analyzes the volume and automatically identifies all of the follicles in the ovary. The software also automatically generates several volumetric parameters of each and every identified follicle.

Eligibility criteria: Inclusion Criteria:

* all women between 25 to 35 years of age
* all women have a normal body mass index(18-25kg/M\^2)
* regular menstrual cycles
* all women would be receiving ovarian stimulation using clomiphene citrate (clomid 50 mg) for ≥5 days starting from 5th day of the cycle then they will be scanned by the same physician using Two Dimensional Ultrasound then Five Dimensional Ultrasound U/S

Exclusion Criteria:

1. medical disorders
2. obesity. BMI\>30

Primary outcomes:
measure: The Mean Follicular Diameter by Two-Dimensional Ultrasound
timeFrame: 10th day of the menstrual cycle
Secondary outcomes:
measure: The Mean Follicular Diameter by Five-Dimensional Ultrasound
timeFrame: 10th day of the menstrual cycle
measure: The Volume-based Diameter (dV) of the Follicle by Five-Dimensional Ultrasound
timeFrame: 10th day of the menstrual cycle
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01914575: Dipole Density Mapping of Right and Left Atrial Supraventricular Tachycardia
Official title: Dipole Density Right (and Left) Atrial Mapping and Assessment of Therapy In Complex Supraventricular Tachycardia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Supraventricular Tachycardia
Lead sponsor: Acutus Medical
Sponsor class: INDUSTRY
First posted: 2013-08-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Use of dipole density mapping to identify activation in complex supraventricular tachycardias


Eligibility criteria: Inclusion Criteria:

1. aged 18 to 75 years
2. scheduled for ablation of atypical atrial flutter or paroxysmal atrial fibrillation
3. able and willing to give informed consent

Exclusion Criteria:

1. implanted prosthetic, artificial, or repaired cardiac valves in the chamber being mapped, permanent pacemaker or ICD leads in the chamber being mapped, and/or hypercoagulopathy or an inability to tolerate anticoagulation .
2. myocardial infarction within the prior two months
3. cardiac surgery within the prior three months
4. intracardiac thrombus
5. clinically significant tricuspid valve regurgitation or stenosis
6. any cerebral ischemic event in the prior six months
7. pregnant or nursing
8. currently enrolled in any other clinical investigation

Primary outcomes:
measure: The number of patients with device-related complications
timeFrame: 7 days
measure: The number of patients for which activation maps can be created
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: St. Vincent's University Hospital
Study officials:
affiliation: St Vincent's University Hospital
name: David Keane, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05652075: PENG and LFCN Block Versus Lumbar Plexus Block for Postoperative Analgesia After Total Hip Arthroplasty
Official title: Efficacy and Safety of Ultrasound Guided Combined Pericapsular Nerve Group Block and Lateral Femoral Cutaneous Nerve Versus Lumbar Plexus Block for Postoperative Analgesia After Total Hip Arthroplasty: Randomized Clinical Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Operative Pain
Regional Block
Keywords: PENG
lumber plexus
hip surgery
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2022-12-15
Enrollment: 66
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Regional anesthesia for postoperative analgesia in THA includes epidural anesthesia and peripheral nerve blocks. However epidural anesthesia has a great role in THA, it has become restricted as perioperative antithrombotic drugs are generally used for orthopedic patients.

the study aim to evaluate and compare efficacy and safety of pericapsular nerve group block (PENG) block and lateral femoral cutaneous nerve versus Lumbar plexus block on postoperative analgesia in hip surgery.


Eligibility criteria: Inclusion Criteria:

(ASA) physical status I to III scheduled for hip surgery aged (30-70) years

Exclusion Criteria:

* Drug allergy,
* Morbid obesity (BMI \>40 kg/m2),
* Coagulopathy,
* Psychiatric disorder,
* Opioid dependence,
* Patient refusal to give informed consent.

Primary outcomes:
measure: Visual analogue scale pain scores
timeFrame: 24 hour
Secondary outcomes:
measure: first analgesic request
timeFrame: 24 hour
measure: total analgesic consumption
timeFrame: 24 hour
measure: First time to ambulate
timeFrame: 24 hours
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia University
state: Minia
Study officials:
affiliation: Minia University, faculty of medicine
name: hassan m. hetta, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02347475: SMA Flow Patterns in Neonatal Transfusion
Official title: Impact of Red Cell Transfusion on Superior Mesenteric Artery Flow Patterns and Intestinal Oxygenation in Fed Preterm Neonates (SPARTAN: Sma PAttern Related to TrAnsfusion in Neonates)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Necrotizing Enterocolitis
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2015-01-27
Enrollment: 7
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prematurity (\<34 completed weeks of gestation at birth) Need for PRBC transfusion

Brief summary: This study aims to measure the changes induced by packed red blood cell (PRBC) transfusion in the superior mesenteric artery (SMA) flow velocity and intestinal oxygenation indices in premature neonates. These changes will be measured in relation to feeding, before and after a blood transfusion. Overall reduction of intestinal perfusion is a risk factor for necrotizing enterocolitis (NEC) - a condition with significant mortality and long term morbidity. Identifying specific patterns of flow velocity and tissue oxygenation changes will allow for planning, studying and implementing risk avoidance and minimization strategies.

Detailed description: Hypothesis: In preterm neonates the anticipated physiologic post-prandial increase in each SMA flow and intestinal perfusion is blunted post transfusion. This is worse in SGA infants and/or in the presence of a PDA.

Questions: 1) Does PRBC transfusion alter postprandial SMA flow increases and intestinal oxygenation indices in preterm infants receiving enteral feeds? 2) Is there a difference in postprandial SMA flow and intestinal perfusion changes in recently transfused SGA infants compared to AGA infants, and in those with and without a PDA? Primary Outcome: Post-prandial SMA flows changes before and after PRBC transfusion.

Secondary outcomes: Pre-post prandial changes in near-infrared spectroscopy (NIRS)-measured intestinal oxygenation parameters before and after PRBC transfusion.

Eligibility criteria: Inclusion Criteria:

* Prematurity (\<34 completed weeks of gestation at birth)
* Need for PRBC transfusion
* Feeding at least 30ml/kg/day at the time of transfusion

Exclusion Criteria:

* Neonates previously diagnosed with gastrointestinal problems such as NEC, intestinal perforation or atresia.
* Infants receiving continuous feeds or less than 30ml/kg/day
* Major congenital or chromosomal abnormalities or infants unlikely to survive
* Skin disruption precluding application of sensors

Primary outcomes:
measure: Post-prandial SMA flows changes before and after PRBC transfusion
timeFrame: Just prior to transfusion until 48 hours post completion of transfusion
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Center
state: Alberta
Study officials:
affiliation: University of Calgary
name: Amelie Stritzke, MD
role: PRINCIPAL_INVESTIGATOR
References: