louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00886756: AZD8529 Single Ascending Dose Study in Healthy Japanese Subjects
Official title: A Phase I, Single-Centre, Randomised, Double-Blind, Placebo Controlled Single-Ascending Dose, Study to Assess the Safety, Tolerability, Pharmacokinetics of AZD8529 in Healthy Male Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Phase I
Japanese healthy volunteer
AZD8529
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-04-23
Enrollment: 48
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This is a Phase I, double-blind, placebo-controlled, randomised within each dose group, single ascending dose study, with the objective to assess the safety, tolerability and pharmacokinetic profile of AZD8529 in healthy Japanese subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy male Japanese subjects aged 20 to 45 years (inclusive)
* Have a body mass index (BMI) between 18 and 27 kg/m 2 (inclusive) and weigh at least 50 kg.least 50 kg.

Exclusion Criteria:

* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
* Any clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, haematology or urinalysis as judged by the Investigator and/or Sponsor.
* Smoking in excess of 5 cigarettes per day or the equivalent within 28 days of Day 1.

Primary outcomes:
measure: To asses the safety:Adverse events, vital signs, physical examinations, telemetry, dECGs, clinical chemistry and haematology labs including testosterone, prolactin, LH, FSH and TSH, and urinalysis.
timeFrame: From screening period to follow-up, 42 days (maiximum).
Secondary outcomes:
measure: To characterize the pharmacokinetics of AZD8529 in plasma and urine.
timeFrame: Blood and urine sampling from pre-dose until 12 days post dose.
measure: To collect and store DNA for future exploratory research
timeFrame: One blood sampling after randomisation.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Richmond Pharmacology Limited
name: Ulrike Lorch, MD MFPM FRCA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03962556: Distribution of Trigger Points in Patient Who Have Myofascial Pain Disorder
Official title: Distribution of Trigger Points in Patient Who Have Myofascial Pain Disorder
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myofascial Pain
Keywords: trigger point,myofacial pain
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2019-05-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Will be conducted in volunteers who applied to our clinic with complaint of TMJ

Brief summary: Myofascial pain alone covers 45.3% of the diagnosis of TMJ. It is defined as palpation sensitivity and regional muscle pain. Clinically muscle pain connects to myofascial trigger points.These trigger points are hypersensitive points located in a tense band of the skeletal muscle, which can be described, causing provoked or spontaneous pain. They are divided into two as active and latent. Those who cause spontaneous pain are active, and those who provoke pain are considered latent.Spasm in the chewing muscles with myofascial pain reduces the patient's pain threshold and quality of life.

Therefore, patients with spasm and TMJ pain in the masticatory muscles should be examined for head and neck muscles, the presence of myofascial trigger points should be determined and the head and neck muscles should be included in physical therapy.

The aim of this study was to determine the presence of myofascial trigger points in patients presenting with pain in the masticatory muscles and TMJ region, and to determine the relationship between the presence of trigger point and the degree of pain.


Eligibility criteria: Inclusion Criteria:

* Will be conducted in volunteers who applied to our clinic with complaint of TMJ

Exclusion Criteria:

* Diagnosed rheumatoid diseases and fibromyalgia.
* Psychiatric drug users.
* Patients who use muscle relaxants.
* TME pathology

Primary outcomes:
measure: masticatory and cervical muscles examination for determining trigger points
timeFrame: first day visit
measure: visual analog scale for pain (VAS)
timeFrame: first day visit
Secondary outcomes:
measure: prevalence of trigger points in facial pain disorder patients
timeFrame: 1 year
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Necmettin Erbakan University/Dentistry Faculty
Study officials:
affiliation: Necmettin Erbakan University/Dentistry Faculty
name: Kubilay Işık
role: STUDY_CHAIR
affiliation: Necmettin Erbakan University/Dentistry Faculty
name: Dilek Menziletoğlu
role: STUDY_DIRECTOR
affiliation: Necmettin Erbakan University/Dentistry Faculty
name: Funda Basturk
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03502356: Addition of Azithromycin to Cefazolin Will Reduce Post CS Infections More Than Cefazolin Only.
Official title: ADDATION OF Azithromycin TO CEFAZOLIN PRE ELECTIVE C S
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Randomized Controll Trial
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-04-18
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Control Group:

This group will include 200women undergoing elective cs. In this group, patients will receive standard antibiotic prophylaxis CEFAZOLIN (at a dose of 1 g) and azithromycin (at a dose of 1g) 2 hours preoperative.

Study Group:

This group will include 200women undergoing elective cs. In this group, patients will receive only standard prophylaxis antibiotic(CEFAZOLIN)
Primary purpose: PREVENTION

Brief summary: The good standard antibiotic prophylaxis pre elective C S is cefazolin and this study will approve addition of azithromycin to cefazolin will reduce post CS infections more than cefazolin only.

Detailed description: Patiants and methods

Randomization:

Patients fulfilling the inclusion criteria will be randomized to two groups. Both two group will receive standard prophylaxis antibiotic CEFAZOLIN (zinol) (at a dose of 1 g) 2 hours preoperative.

Control Group:

This group will include 200women undergoing elective cs. In this group, patients will receive standard antibiotic prophylaxis CEFAZOLIN (at a dose of 1 g) and azithromycin (at a dose of 1g) 2 hours preoperative.

Study Group:

This group will include 200women undergoing elective cs. In this group, patients will receive only standard prophylaxis antibiotic(CEFAZOLIN)

Inclusion criteria:

* Gestational age of 37 0/7 weeks and greater
* Elective cesarean section
* Medicaly free pregnant women

Exclusion criteria:

* a known allergy to azithromycin
* obstetric complications
* azithromycin use within 7 days before randomization
* chorioamnionitis or other infection requiring postpartum antibiotic therapy
* Pre-gestational diabetes

Eligibility criteria: Inclusion Criteria:

* Gestational age of 37 0/7 weeks and greater
* Elective cesarean section
* Medicaly free pregnant women

Exclusion Criteria:

* a known allergy to azithromycin
* obstetric complications
* azithromycin use within 7 days before randomization
* chorioamnionitis or other infection requiring postpartum antibiotic therapy
* Pre-gestational diabetes

Primary outcomes:
measure: endometritis
timeFrame: 6 weeks after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams
state: Elabasy
Study officials:
affiliation: ain shams
name: mohamed 20 amar, md
role: STUDY_CHAIR
References:
Clinical trial NCT04950556: The Effects of Pelvic Floor Muscle Training in Women With Overactive Bladdder
Official title: The Effects of Pelvic Floor Muscle Training in Women With Overactive Bladdder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overactive Bladder
Lead sponsor: Ataturk Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-07-06
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly divided into two groups (control and exercise) for treatment.
Primary purpose: TREATMENT

Brief summary: The aim of our study is to investigate the effects of pelvic floor muscle training (PFMT) on pelvic floor muscle strength, sexual functions, bladder symptoms and quality of life in women with overactive bladder (OAB).

Detailed description: Overactive bladder (OAB) is defined by the International Continence Association as an "urgency with or without urge urinary incontinence, often accompanied by frequency and nocturia." Accordingly, pelvic floor muscle training (PFMT) plays an important role in the management of OAB. However, a recent systematic review suggests that PFMT is insufficient against OAB.

Eligibility criteria: Inclusion Criteria:

* Having a diagnosis of overactive bladder
* Being volunteer

Exclusion Criteria:

* have a neurological disorder
* only those with stress urinary incontinence
* presence of advanced pelvic organ prolapse (stage 3-4)
* Having a mental problem that will prevent cooperation in evaluation and / or applications
* Women with the presence of malignant condition

Primary outcomes:
measure: Pelvic floor muscle strength
timeFrame: change from baseline at 6 weeks
measure: Sexual Function
timeFrame: change from baseline at 6 weeks
Secondary outcomes:
measure: OAB symptoms
timeFrame: change from baseline at 6 weeks
measure: Urinary frequency, nocturia and the number of urinary incontinence
timeFrame: change from baseline at 6 weeks
measure: Life quality
timeFrame: change from baseline at 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Ankara Yildirim Beyazıt University
name: Seyda Toprak Celenay
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04486456: Epidemiological Study on Anemia and Iron Deficiency in Pregnancy in Medical Institutions in Some Areas of China
Official title: Epidemiological Study on Anemia and Iron Deficiency in Pregnancy in Medical Institutions in Some Areas of China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prevalence
Keywords: Iron deficiency
Anemia during pregnancy
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2020-07-24
Enrollment: 20000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnancy patients

Brief summary: The purpose of this study is to describe the prevalence of anemia and iron deficiency in pregnancy through a multi-center, prospective follow-up study . To explore the influence factors of anemia and iron deficiency in pregnancy; to explore the influence of anemia and iron deficiency in pregnancy on maternal and fetal outcomes.

Detailed description: 1. To understand the epidemiological characteristics of anemia and iron deficiency in pregnancy and describe the epidemiological situation of anemia and iron deficiency.
2. To explore the influence factors of anemia and iron deficiency in pregnancy.
3. To explore the influence of anemia and iron deficiency during pregnancy on the pregnancy outcome of mothers and infants.

Eligibility criteria: Inclusion Criteria:

* Regular prenatal check-ups were conducted in the hospitals participating in the study, and pregnant women who planned to give birth in hospital were established a maternity health manual
* 18 years and older
* Patients have to agree to participate by signing a consent

Exclusion Criteria:

* have severe chronic diseases with Pre-pregnancy
* Suffer from severe mental illness

Primary outcomes:
measure: Hb
timeFrame: Completed by observation，an average of 1 year
Secondary outcomes:
measure: SF
timeFrame: Completed by observation，an average of 1 year
Other outcomes:
Locations:
Study officials:
affiliation: The First Affiliated Hospital of Peking University
name: Xia H Yang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00990756: A Phase 1 Study To Evaluate The Safety And Tolerability Of Different Doses Of PF-03526299 In Healthy Adult Volunteers
Official title: A Double Blind (3rd Party Open), Randomised, Placebo Controlled, Dose Escalation Study To Investigate The Safety, Toleration, And Pharmacokinetics Of Multiple Inhaled Doses Of PF-03526299 In Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-10-07
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate safety and toleration of multiple inhaled doses as well as the time course of PF-03526299 concentration in the blood following dosing by dry powder inhaler.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects and females of non-childbearing potential between the ages of 21 and 55 years.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m\^2; and a total body weight \>50 kg (110 lbs).
* Subjects who had a normal chest X-ray in the previous 6 months prior to Screening

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* A positive urine drug screen.
* History of regular alcohol consumption exceeding 21 drinks/week for males and 14 drinks/week for females.

Primary outcomes:
measure: Safety/toleration: Adverse events, vital signs, 12 lead ECG, blood and urine safety tests and physical examination.
timeFrame: 17 days
Secondary outcomes:
measure: Pharmacokinetic parameters: Plasma Day 1: Cmax, Tmax, AUCτau.
timeFrame: Day 1 - 17
measure: Plasma Day 7: Cmax, Tmax.
timeFrame: 7 Days
measure: Plasma Day 14: Cmax, Tmax, CL/F, AUCτau, t½, accumulation ratio, time to steady state.
timeFrame: 14 Days
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01994356: Physician Self Disclosure of IUC Use
Official title: Pilot Study of Physician Self-disclosure of Personal Intrauterine Contraceptive Use Versus Usual Counseling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Keywords: Contraceptive counseling
Physician self disclosure
Satisfaction
Intrauterine contraceptive use
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 132
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: As many as one-third of female healthcare providers use intrauterine contraception (IUC), but only about 8 percent of US women overall do. This begs the question: Might physician self-disclosure of personal IUC use increase IUC use among patients? However, the positive or negative impact of physician self disclosure on IUC uptake or patient satisfaction is generally unknown. The purpose of this study was to evaluate if physician self-disclosure of personal IUC use increases patient use of IUC or impacts patients' satisfaction with their clinical encounter.

Detailed description: We performed a prospective randomized block design pilot trail of usual contraceptive counseling versus usual counseling plus physician self-disclosure of personal intrauterine contraceptive use.

Eligibility criteria: Inclusion Criteria:

* reproductive age
* currently sexually active
* scheduled for benign gynecology visit, annual exam, or family planning visit

Exclusion Criteria:

* seeking pregnancy within 1 year
* currently using IUC
* prior sterilization procedure
* currently pregnant

Primary outcomes:
measure: Intrauterine contraceptive use
timeFrame: immediately following clinical encounter and at 2 months
Secondary outcomes:
measure: Satisfaction with clinical encounter
timeFrame: immediately following clinical encounter and at 2 months
Other outcomes:
measure: Satisfaction with contraceptive method
timeFrame: immediately following clinical enocunter and at 2 months
measure: Satisfaction with provider
timeFrame: immediately following clinical encounter and at 2 months
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Medical Center
state: Michigan
Study officials:
References:
Clinical trial NCT03507556: Regeneration of Immature Teeth. Case Series
Official title: The Regenerative Potential of Immature Necrotic Teeth With Apical Periodontitis Based on Clinical and Radiographic Assessments
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Revascularization
Keywords: immature teeth, necrotic teeth
Lead sponsor: Jordan University of Science and Technology
Sponsor class: OTHER
First posted: 2018-04-25
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Revascularization for immature necrotic permanent teeth with apical periodontitis.
Primary purpose: TREATMENT

Brief summary: This clinical study aims to investigate the predictability of revascularization procedure of immature necrotic human permanent teeth with apical periodontitis. The quality of root development (thickness and length) will be assessed radiographically.

Detailed description: All teeth will be disinfected using either triple antibiotic paste (a mixture of metronidazole, ciprofloxacin and amoxicillin mixed with sterile glycole) or non setting calcium hydroxide applied to the pulp space with a sterile lentulospiral and then closed temporarily with a sterile sponge and temporary restoration for 2-3 weeks to allow disinfection of the canals teeth will be reentered under rubber dam isolation and all intracanal medicaments will be washed out from the canal using 10 ml of 2.5% sodium hypochlorite and 20 ml of Ethylene diamine tetra acetic acid (EDTA). Then, a sterile endodontic file will be inserted past the canal terminus into the periapical tissues to induce bleeding to fill the canal space as much as possible and subsequently sealed with a double coronal seal using bioceramic repair material and composite filling. All the teeth will be monitored clinically and radiographically on a biannual basis.

Eligibility criteria: Inclusion Criteria:

1. Teeth diagnosed with necrotic pulp with/without evidence of apical periodontitis.
2. An immature/open apex.
3. Tooth does not need post and core restoration.
4. Medically healthy patients with no known allergy to used materials.

Exclusion Criteria:

1. Medically compromised patient,
2. Teeth with periodontal involvement
3. Teeth with vertical root fractures,
4. Non-restorable teeth,

Primary outcomes:
measure: complete healing
timeFrame: from start of intervention up to 100 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: Dental health center
Study officials:
References:
Clinical trial NCT05471609: Sustained Release Oral Formulation for Treatment of Parkinson's Disease
Official title: Sustained Release Oral Formulation for Treatment of Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: EARLY_PHASE1
Conditions: Idiopathic Parkinson Disease
Keywords: Idiopathic Parkinson Disease
levodopa/carbidopa
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-07-25
Enrollment: 6
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 3 different assemblies with 3 different formulations (A,B \& C) will be used.
Primary purpose: TREATMENT

Brief summary: Achieving sustained blood levels of carbidopa/levodopa has been a challenge in the treatment of PD and although levodopa remains the most commonly used drug, motor fluctuations remain a major disability especially in advanced Parkinson's disease. The aim of this study is to determine the efficacy of a novel oral carbidopa-levodopa formulation in achieving a sustained blood level of levodopa and carbidopa in PD.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with idiopathic PD
* Experiencing motor fluctuations

Exclusion Criteria:

* Inability to consent for thmeselves
* Inability to fast

Primary outcomes:
measure: Carbidopa/levodopa serum level Efficacy of the delivery method
timeFrame: 5 times, every 60 mins for a total of 6 hours after administration
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Khalaf Bushara, MD,FRCP
role: PRINCIPAL_INVESTIGATOR
References: