louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06199544: Effect of Unani Medicine for the Management of Anomalies Associated With Polycystic Ovarian Syndrome
Official title: Effect of Unani Medicine Coded Formulations for the Management of Anomalies Associated With Polycystic Ovarian Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Comparative Study
Lead sponsor: Hamdard University
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial
Primary purpose: TREATMENT

Brief summary: Currently available medications for PCOS are symptom(s) oriented but have limitations because of its complex pathophysiology. The most preferred drug against PCOS is metformin which act as an insulin sensitizer to improve insulin-glucose metabolism and anovulatory cycles in PCOS. However, its use is associated with various side effects such as bloating, diarrhea and nausea. Thus, it is imperative to explore various other alternatives to combat this gynecological problem.

Detailed description: Polycystic ovarian syndrome (PCOS) is a common endocrine disorder in reproductive age women, with a prevalence between 5%-15%. Currently, sedentary lifestyle, excessive intake of junk food and increasing prevalence of obesity has been associated with rise in the incidence of PCOS.

Eligibility criteria: Inclusion criteria No complications record of reproductive system, 4) PCOS diagnosed using Rotterdam criteria fulfilling any two of the following: (i) Menstrual irregularity or oligo-/anovulation, (ii) Hyperandrogenism (clinically and/or biochemically), (iii) Polycystic appearance on ultrasound

Exclusion criteria

1) Patients with severe adverse drug reactions, 2) Record of cardiovascular, diabetes, hepatic and neoplastic disorders or other concurrent medical illnesses, 3) Hormonal contraceptive used within 6 months, or anti-obesity drugs within 3 months of the study, 4) Irregular menstrual bleeding other than PCOS and 5) Positive pregnancy test.

Primary outcomes:
measure: Improvement in the menstrual regularity of the patient
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Shifa ul mulk memorial hospital
state: Sindh
Study officials:
References:
Clinical trial NCT03314844: Plasma Glucagon-like Peptide-1 Levels and In-hospital Complications in ST-segment Elevation Myocardial Infarction
Official title: Plasma Glucagon-like Peptide-1 Levels Predict In-hospital Complications in ST-segment Elevation Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: STEMI - ST Elevation Myocardial Infarction
Glucagon-like Peptide-1
Bleeding
Complications
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2017-10-19
Enrollment: 564
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PLA general hospital (PLAGH) is a large national tertiary-care center in the Beijing, China. The investigators enrolled all patients consecutively hospitalized in PLAGH, with a diagnosis of STEMI and needed PCI

Brief summary: Glucagon-like peptide-1 (GLP-1), produced mainly in enteroendocrine cells, participates in energy homeostasis and glucose metabolism by regulating islet hormone secretion, gastrointestinal motility, and food intake, making GLP-1 agonist a treatment for diabetes and obesity. Pre-clinical and clinical studies have demonstrated that GLP-1 also has cardio-protection effects. GLP-1 agonists is able to improve markers of cardiac function, reduce myocardial infarct size and post-myocardial infarction remodeling in experimental myocardial infarction. And GLP-1 infusion improved left ventricular function and increases myocardial salvage in patients with acute myocardial infarction (AMI). The investigators' previous study found that GLP-1 analogues attenuated ischemia-reperfusion induced apoptosis of stem- and myocardial microvascular endothelial cells, and liraglutide (a GLP-1 analog) usage during hospital stay can prevent no-reflow and improve heart function in AMI. Therefore, the investigators carried out a cohort study to evaluate the association between plasma GLP-1 and in-hospital complications in patients with ST-segment elevation myocardial infarction.


Eligibility criteria: Inclusion Criteria:

* a diagnosis of STEMI and needed PCI

Exclusion Criteria:

* patients with cancer patients who used DPP4 inhibitor patients who used GLP1 analogue

Primary outcomes:
measure: in-hospital complications
timeFrame: Time Frame: up to 2 week after PCI (until discharge)
Secondary outcomes:
measure: in-hospital major adverse cardiac or cerebrovascular events
timeFrame: Time Frame: up to 2 week after PCI (until discharge)]
measure: in-hospital major bleeding
timeFrame: Time Frame: up to 2 week after PCI (until discharge)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06550544: Hysteroscopic Guided Versus Ultrasound Guided Extraction of Retained IUD
Official title: Hysteroscopic Guided Versus Ultrasound Guided Extraction of Retained IUD A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Contraceptive Device; Complications
Keywords: IUD
Office hysteroscopy
Ultrasound
Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Bedaya Hospital
First posted: 2024-08-13
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this randomized controlled study is to compare the pain experienced during extraction of retained IUD by office hysteroscopy with the pain experienced during extraction of retained IUD under ultrasound guidance . Moreover, the success of both procedures was compared. Various subgroups (patients who delivered only by Caesarean section, patients who delivered virginally, nulliparous women and menopausal patients) in both groups are compared.

Detailed description: The intrauterine device (IUD) is a commonly used long-acting, effective and reversible method of contraception. The recommended way to remove a IUD is by grasping the threads with forceps and applying gentle traction until the IUD is extracted from the external os.

Absent of the threads at the time of IUD removal is reported in 4.5 to 18% of cases. If the IUD is present in the uterus and threads are not visible , its removal in the office setting can still be achieved in about 80% of patients with the use of alligator forceps or string retrieval devices, hooks or clamps. However, blind manipulation may cause uterine perforation . In cases where such devices have failed (retained IUD ), If in office extraction of IUD by these instruments failed, removal of this retained IUD in the operating room is often employed because cervical dilatation and regional or general anesthesia are needed.

In the last decade, several studies reported in office extraction of retained IUD by office hysteroscopy or under ultrasound guidance. No studies compared the efficacy or safety of these procedures

Eligibility criteria: Inclusion Criteria:

* Patients with retained IUD

Exclusion Criteria:

* Active pelvic infection
* Viable intrauterine pregnancy
* Cervical pathology

Primary outcomes:
measure: Intensity of pain
timeFrame: Immediately after the procedure
Secondary outcomes:
measure: Success of IUD extraction
timeFrame: Immediately after the procedure
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Obstetrics &Gynecology Department , Faculty of medicine ,Cairo university
Study officials:
affiliation: Cairo University
name: Usama M Fouda, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Townsend L, Luxford E, Mizia K. Effectiveness of ultrasound-guided removal of intrauterine devices. Aust N Z J Obstet Gynaecol. 2022 Oct;62(5):800-802. doi: 10.1111/ajo.13584. Epub 2022 Jul 11.
Clinical trial NCT00766844: Cervical Spinal Cord Stimulation for the Prevention of Cerebral Vasospasm
Official title: Cervical Spinal Cord Stimulation for the Prevention of Cerebral Vasospasm Following Aneurysmal Subarachnoid Hemorrhage Using MTS Trial System 3510
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Aneurysmal Subarachnoid Hemorrhage
Keywords: vasospasm
spinal cord stimulation
aneurysm
subarachnoid hemorrhage
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2008-10-06
Enrollment: 12
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: PREVENTION

Brief summary: The study investigates safety, feasibility and effectiveness of cervical spinal cord stimulation (SCS) in prevention of cerebral arterial vasospasm following aneurysmal subarachnoid hemorrhage (aSAH).

It is postulated that 2 week long stimulation of the cervical spinal cord using an implanted epidural electrode will prevent or decrease severity of cerebral arterial vasospasm following aSAH.

Detailed description: Continuous stimulation of the cervical spinal cord for 14 days after electrode implantation (within 3 days after aneurysmal subarachnoid hemorrhage). The single-arm single-institution non-randomized prospective study evaluates effects of cervical spinal cord stimulation on prevention of cerebral arterial vasospasm.

The patients are followed for 12 months after completion of stimulation.

Eligibility criteria: Inclusion Criteria:

* Age 18-65
* Subarachnoid hemorrhage (SAH) within 72 hours
* Ruptured aneurysm confirmed by angiography of CT angiography
* Fisher grade 2-4
* Hunt \& Hess grade 2-4
* Aneurysm is secured
* Ability to obtain informed consent

Exclusion Criteria:

* Pregnancy
* Allergy to IV contrast or to any component of SCS system
* Non-aneurysmal SAH
* Previous cervical spine surgery or any anomaly of cervical spine that would prevent electrode insertion
* Coagulopathy

Primary outcomes:
measure: Prevention of cerebral vasospasm
timeFrame: 14-17 days after aSAH
Secondary outcomes:
measure: Any complication of spinal cord stimulation
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois Medical Center in Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Konstantin V Slavin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Slavin KV, Vannemreddy P. Cervical spinal cord stimulation for prevention and treatment of cerebral vasospasm after aneurysmal subarachnoid hemorrhage: clinical and radiographic outcomes of a prospective single-center clinical pilot study. Acta Neurochir (Wien). 2022 Nov;164(11):2927-2937. doi: 10.1007/s00701-022-05325-4. Epub 2022 Aug 3.
Clinical trial NCT06505044: Effect of Aerobic Exercise Versus Resistance Exercise on Bone Density in Postmenopausal Diabetic Women
Official title: Effect of Moderate Intensity Aerobic Exercise Versus Resistance Exercise on Bone Density in Postmenopausal Diabetic Women
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Osteoporosis
Lead sponsor: Deraya University
Sponsor class: OTHER
First posted: 2024-07-17
Enrollment: 50
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Osteoporosis is a significant public health issue, especially among postmenopausal women with diabetes, and its prevalence is increasing. This trial aims to determine the influence of moderate intensity aerobic exercise vs resistance exercise on bone mineral density among postmenopausal diabetic women.

Detailed description: has diabetes. Postmenopausal Osteoporosis (PMO) is an increasingly serious metabolic bone disease in the world, which generally develops in middle-aged and elderly women and postmenopausal women, and it is characterized by low bone mass and microstructure degradation of bone tissues. there are complex pathophysiological effects between them: T2D directly affects bone metabolism and strength. Some antidiabetic drugs affect bone metabolism, and diabetes complications are related to the risk of falls and subsequent fractures. Patients with T2D have higher trabecular and lower cortical bone density, leading to lower bone intensity. Exercise is considered a highly relevant component in the prevention and treatment of osteoporosis and fracture reduction. Exercise greatly affects bone geometry as it increases periosteal apposition through increasing osteoblast formation. In addition to influencing bone mineral density, exercise can improve muscle function to potentially decrease fall risk through improved balance and strength.

The purpose of this study was to investigate the effect of moderate-intensity aerobic exercise versus resistance exercise on bone mineral density in postmenopausal diabetic women.

Eligibility criteria: Inclusion Criteria:

* Fifty women postmenopausal obese women
* (BMI) 30 -35 kg/m2
* their age ranges from 50 to 60 years old and
* complain of diabetic type 2 for 10 years ago.

Exclusion Criteria:

* women with renal or liver disease,
* cardiac or chest disease psychological problems,
* cognitive problems are excluded from the study.
* Any women who have therapeutic problems that will interfere with performing exercise or affection BMD will be excluded from this study.

Primary outcomes:
measure: The bone mineral density (BMD)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Soad A. Mohamad
Study officials:
References:
Clinical trial NCT04295044: Effect of High Protein Diet in Stroke Patients With Low Muscle Mass
Official title: Effect of High Protein Diet in Stroke Patients With Low Muscle Mass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ischemic Stroke
Diet, Healthy
Muscle Loss
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2020-03-04
Enrollment: 110
Sex: ALL
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Our prior studies demonstrated that dehydration was a predictor for poor outcome in stroke and Blood urea nitrogen/Cr ratio-based saline hydration therapy in patients with acute ischemic stroke may increase the rate of favorable clinical outcome with functional independence at 3 months after stroke. However, dehydration is likely to be only a part of representation in poor nutrition status and physical fragility for a stroke patient.

Our prior study found that acute stroke patients admitted to neurological intensive care unit with low urinary creatinine excretion rate (CER), a marker of muscle mass, was associated with poor outcome at 6 months after stroke. An animal study suggested inadequate food and water intake determine mortality following stroke in mice and nutritional support reduced the 14-day mortality rate from 59% to 15%. A study also showed that high protein intake was associated with a better outcome in previous cardiovascular events.

We will calculate CER based on published equation. Based on our prior study, acute stroke patients with their CER\<1500 mg/day will be enrolled. A randomized controlled trial will be conducted and patients will be randomly assigned to high protein diet or normal protein diet for at least 2 weeks. We plan to enroll 300 patients, with 150 patients in ach group, during 3-year study period. We will consult dietitians for arrangement of their diet. We assume that patients receiving high protein diet will have higher opportunity to walk independently (modified Rankin Scale 0-1) at 3 month after stroke.


Eligibility criteria: Inclusion Criteria:

1. acute ischemic stroke during hospitalization
2. eGFR \>30
3. urine albumin creatinine ratio \< 30 mg/g
4. urinary creatinine excretion rate (CER) \< 1500g/day

Exclusion Criteria:

1. chronic kidney disease stage 4 or 5 (i.e. eGFR \< 30)
2. proteinuria (protein 1+ or more in urine routine)
3. known impairment of functional status (mRS ≥ 2) prior to the index stroke
4. refuse to participate in this study.

Primary outcomes:
measure: modified Rankin Scale 0-1
timeFrame: 3 months
Secondary outcomes:
measure: modified Rankin Scale 0-2
timeFrame: 3 months
Other outcomes:
Locations:
city: Chiayi City
country: Taiwan
facility: Chang Gung Memorial Hospital, Chiayi Branch
Study officials:
References:
Clinical trial NCT05831644: A Trial to Evaluate the Effect of C21 on Endothelial Dysfunction in Subjects With Type 2 Diabetes
Official title: A Randomized, Double-blind, Placebo-controlled, 2-way Cross-over Trial Evaluating the Effect of C21 on Endothelial Dysfunction and Safety in Subjects With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type2diabetes
Endothelial Dysfunction
Lead sponsor: Vicore Pharma AB
Sponsor class: INDUSTRY
First posted: 2023-04-26
Enrollment: 11
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This trial is a single-centre, randomized, double-blind, placebo-controlled, 2-way cross-over phase 1b trial evaluating the pharmacodynamic effect of C21 on endothelial dysfunction and safety in subjects with type 2 diabetes mellitus (T2DM).


Eligibility criteria: Inclusion Criteria:

* Male or female patient aged ≥ 40 years at the time of the screening visit (Visit 1).
* Documented diagnosed with T2DM prior to the screening visit (Visit 1).
* An RHI score ≤ 2 as assessed by EndoPAT at the time of the screening visit (Visit 1).

Exclusion Criteria:

* Known, active hepatitis B, C, or human immunodeficiency virus (HIV) infection (i.e., HIV with a CD4 (cluster of differentiation 4) count \<500 cells/mm³).
* Impaired hepatic function or clinically significant liver disease, which in the investigator's opinion makes the subject inappropriate for this trial.
* Severe renal impairment (i.e., estimated glomerular filtration rate (eGFR) ≤30 mL/min/1.73 m2).
* Prolonged QTcF (QT interval with Fridericia's correction) (\>450 ms), atrial fibrillation, clinically significant arrhythmia or other clinically significant abnormality in the resting ECG (electrocardiogram) at screening (Visit 1), as judged by the investigator.
* Unstable or deteriorating cardiac condition.
* Malignancy within the past 5 years with the exception of in situ removal of basal cell carcinoma and cervical intraepithelial neoplasia grade I.

Primary outcomes:
measure: Pharmacodynamic Effect
timeFrame: Maximum 15 days after first Investigational Medical Product (IMP) intake.
Secondary outcomes:
measure: Augmentation Index (AI) Score as Measured by EndoPAT (Endothelial Pulse Amplitude Tonometry (PAT)). The AI Score Reported is Change Between Baseline Value and Value at the Visit Where Either C21 or Placebo is Taken.
timeFrame: Maximum 15 days after first Investigational Medical Product (IMP) intake.
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Skånes universitetssjukhus
Study officials:
References:
Clinical trial NCT01518894: A Study To Examine The Safety, Tolerability And Pharmacokinetics Of PF-04958242 In Psychiatrically Stable Subjects With Schizophrenia
Official title: A Randomized, Double-Blind, Placebo Controlled, Sponsor Open, Phase 1b Study To Examine The Safety, Tolerability And Pharmacokinetics Of PF-04958242 In Psychiatrically Stable Subjects With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Keywords: PF-04958242
multiple dose
Safety
schizophrenia
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2012-01-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: To evaluate the safety and tolerability of multiple, ascending doses of PF-04958242 administered orally to psychiatrically stable subjects with schizophrenia receiving antipsychotic and adjunctive medication.

Detailed description: This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.

Eligibility criteria: Inclusion Criteria:

* Psychiatrically stable subjects with schizophrenia
* Evidence of stable schizophrenia symptomatology ≥ 3 months
* Score on MCCB Letter-number span + Spatial span subtest \< 40.

Exclusion Criteria:

* History of seizures or of a condition with risk of seizures
* History of abnormal EEG.
* Pregnant or nursing females, and women of child bearing potential

Primary outcomes:
measure: Composite of Pharmacokinetics measured at 0.25, 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24 hours after dosing on Day 1
timeFrame: Day 1 - Day 2
measure: Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 4
timeFrame: Day 4
measure: Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 7
timeFrame: Day 7
measure: Composite of Pharmacokinetics measured at 0.25, 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24, 48, 72, 120 hours after dosing on Day 14
timeFrame: Day 14 - Day 17
measure: Composite of urine Pharmacokinetics measured for 24 hours post-dose on Day 14
timeFrame: Day 14 - Day 15
Secondary outcomes:
measure: Cogntion - CogState
timeFrame: Day 0, 1, 6, 13
measure: Cognition - Matrics Consensus Cognition Battery
timeFrame: Day 0, 1, 6, 13
measure: Drug Effect Questionnaire liking scale
timeFrame: Day, 1, 14
measure: Cognitive training
timeFrame: Days 0 - 13
measure: Columbia Suicide Severity Rating Scale
timeFrame: Day 0, 1, 7, 14, 17, 23
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Pfizer Investigational Site
state: California
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: