louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02908867: Therapeutic Strategies in Sexual Function
Official title: Therapeutic Strategies in Sexual Function of Men With Spinal Cord Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Male Sexual Dysfunction
Spinal Cord Injury
Keywords: Sexuality
Spinal cord injuries
Complementary Therapies
Medicinal plants
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2016-09-21
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study involving 24 men with spinal cord injury, recruited in reference services in spinal cord injury Recife (PE). Aged between 18 and 60 years with a clinical diagnosis of traumatic spinal cord injury, injury time less than six months, heterosexual and sexually active. The study excluded patients who had erectile dysfunction attributed to endocrine or metabolic disease order, those who underwent surgery in the genital area, such as radical prostatectomy or penile implant and cognitive impairment.

Brief summary: Objectives: To know the main therapeutic strategies used by men with spinal cord injury in sexual dysfunctions.

Detailed description: Methods: This is a descriptive observational study involving 24 men with a mean age of 32.62 (CI 28.65 to 36.60), with spinal cord injury, recruited in reference services in spinal cord injury Recife (PE). The subjects underwent neurological evaluation in accordance with the guidelines of the International Standards for Neurological Examination and Functional classification of Spinal Cord Injury (ISNCSCI), the American Spinal Injury Association (ASIA), assessment of sexual function through the Erectile Function of International Index (IIEF) and answered a semi-structured form to identify therapeutic strategies used in sexual function. To collect information about medicinal plants, a search was made in the surroundings of public markets located in the Metropolitan Region of Recife (PE).

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of traumatic spinal cord injury
* injury time less than six months
* heterosexual
* sexually active

Exclusion Criteria:

* patients who had erectile dysfunction attributed to endocrine or metabolic disease order
* those who underwent surgery in the genital area, such as radical prostatectomy or penile implant
* cognitive impairment

Primary outcomes:
measure: Therapeutic Strategies
timeFrame: one day
Secondary outcomes:
measure: level of neurological lesion
timeFrame: one day
measure: Degree of lesion
timeFrame: one day
measure: Male sexual dysfunction
timeFrame: one day
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Josepha Karinne de Oliveira Ferro
state: Pernambuco
Study officials:
affiliation: Universidade Federal de Pernambuco
name: Josepha KO Ferro, master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03235167: Cytidine-phosphate-guanosine (CpG) DNA in Hepatocellular Carcinoma Combination Therapy
Official title: Cytidine-phosphate-guanosine (CpG) DNA in Hepatocellular Carcinoma Combination Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Hepatocellular Carcinoma
Lead sponsor: Dalian University
Sponsor class: OTHER
First posted: 2017-08-01
Enrollment: 100
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: to observe the outcome of hepatocellular carcinoma patients under the combination treatment of transcatheter arterial chemoembolization (TACE) and CpG DNA


Eligibility criteria: Inclusion Criteria:

* TNM (tumor node metastasis ) staging with non distant metastasis; no other tumors

Exclusion Criteria:

* having received previous treatment for liver cancer

Primary outcomes:
measure: survival time
timeFrame: 5 years
measure: metastasis free survival time
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The Affiliated Zhongshan Hospital of Dalian University
name: xiaolin Yuan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02690467: Efficacy, Safety and Acceptability of the New Pen Needle 34gx3,5mm.
Official title: Efficacy, Safety and Acceptability of the New Pen Needle 33G x 4 mm: a Cross-over Randomised Non Inferiority Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Insulin therapy
Needle
Lead sponsor: Center for Outcomes Research and Clinical Epidemiology, Italy
Sponsor class: OTHER
Collaborators: name: Artsana S.p.a.
First posted: 2016-02-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the non-inferiority of a new Pic Insupen 34Gx3,5mm needle vs. a 32Gx4mm needle in terms of metabolic control, safety and acceptability in patients with diabetes treated with insulin.


Eligibility criteria: Inclusion Criteria:

* Patients with type 1 or type 2 diabetes
* Age \>= 18 years
* Multiple daily injections of insulin for at least 6 months
* Signed informed consent

Exclusion Criteria:

* Pregnancy or or breast feeding
* Inability to fill in the questionnaire
* Combined therapy for diabetes (oral drugs associated with insulin injections)
* Any medical condition that could interfere with the study according to the investigator's opinion

Primary outcomes:
measure: Fructosamine levels
timeFrame: 3 weeks
Secondary outcomes:
measure: Glycemic variability expressed as the standard deviation of fasting blood and postprandial glucose levels
timeFrame: 3 weeks
measure: Daily insulin dose
timeFrame: 3 weeks
measure: Body weight
timeFrame: 3 weeks
measure: Pain
timeFrame: 3 weeks
measure: Patient satisfaction measured by a questionnaire
timeFrame: 3 weeks
measure: Number of patients with hypoglycaemia
timeFrame: 3 weeks
measure: Number of hypoglycaemia episodes
timeFrame: 3 weeks
measure: Number of episodes of insulin leakage at injection site
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Treviglio
country: Italy
facility: U.O. Malattie Metaboliche e Diabetologia - Ospedale Treviglio
state: BG
city: Mariano Comense
country: Italy
facility: Struttura Semplice Dipartimentale di Diabetologia e Malattie Metaboliche - Az. Osp. S. Anna - PO Cantù
state: CO
city: Desio
country: Italy
facility: Struttura Semplice Dipartimentale Diabetologia, Endocrinologia e Nutrizione Clinica - Az. Osp. Desio e Vimercate
state: MI
city: Roma
country: Italy
facility: Struttura Complessa Dietologia - Diabetologia Malattie Metaboliche - Ospedale Pertini
state: RM
Study officials:
References:
citation: De Berardis G, Scardapane M, Lucisano G, Abbruzzese S, Bossi AC, Cipponeri E, D'Angelo P, Fontana L, Lancione R, Marelli G, Sciangula L, Nicolucci A. Efficacy, safety and acceptability of the new pen needle 34G x 3.5 mm: a crossover randomized non-inferiority trial; AGO 02 study. Curr Med Res Opin. 2018 Sep;34(9):1699-1704. doi: 10.1080/03007995.2018.1491396. Epub 2018 Jul 5.
Clinical trial NCT04685967: Clinical Evaluation of a Restorative Glass Ionomer and a Bulk-fill Composite Resin
Official title: Clinical Evaluation of a Restorative Glass Ionomer and a Bulk-fill Composite Resin
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tooth Disease
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-12-28
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The clinical performance of a restorative glass ionomer and bulk-fill resin composite in class II restorations will be evaluated and compared. After recruiting participants with at least 2 approximal caries lesions, all restorations will be placed by a single clinician. All caries lesions will be removed before restoring. Cavities will be divided into two groups: a restorative glass ionomer \[Equia Forte HT, GC, Tokyo, Japan (EHT)\] and bulk-fill composite resin \[SonicFill2, Orange, CA, USA (SBF)\] All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using modified United States Public Health Service (USPHS) criteria after a week (baseline) 6, 12, 24, 36 and 48 months. Descriptive statistics will be performed using chi-square tests.


Eligibility criteria: Inclusion Criteria:

* age range will be 18 to 65
* patients should have at least 2 approximal caries lesions require restoration
* healthy periodontal status
* a good likelihood of recall availability

Exclusion Criteria:

* poor gingival health
* adverse medical history
* potential behavioral problems

Primary outcomes:
measure: Clinical performances of different restorative systems according to USPHS criteria
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References:
Clinical trial NCT05722067: Improvement of Fertilization Rate and Embryo Quality by Treating Calcium Ionophore in IVF Patients: a Sibling Oocyte Control Study
Official title: Improved the Low Fertilization Rates and Increased the High-quality Embryogenesis by Treatment with Calcium Ionophore GM508 CultActive Optimized Medium in Vitro Fertilization (IVF) Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: IVF
Infertility
Artificial Oocyte Activation
Keywords: artificial oocyte activation
calcium ionophore
ivf
poor responder
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2023-02-10
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: GM508 CultActive is a bicarbonate buffered reagent and ready-to-use designed to investigate oocytes of patients with failed fertilization after previous Intracytoplasmatic Sperm Injection cycles. The investigators hypothesize that GM508 CultActive will improve the fertilization rate and embryo development of such IVF patients (a history of poor fertilization, a history of poor embryo quality, and over 40 years old expected challenging to conceive).


Eligibility criteria: Inclusion Criteria:

* Low fertilization rate in previous IVF cycle (\<30%), or
* Poor embryo developmental problems in previous IVF cycle, or
* Diminished ovarian reserve (AMH\<1.2 or AFC\<5) and/or more than 40 y/o.

Exclusion Criteria:

* Without or just one oocyte picked up

Primary outcomes:
measure: fertilization rate
timeFrame: Day 1
Secondary outcomes:
measure: blastocyst formation rate
timeFrame: Day 5
measure: top-quality blastocyst formation rate
timeFrame: Day 5
measure: pregnancy outcome
timeFrame: 1 year
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
References:
Clinical trial NCT05777967: Efficacy and Safety of FF-31501 in Meniscus Tear Patients
Official title: A Phase 3 Single-arm Multicenter Study of FF-31501 in Meniscus Tear Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Meniscus Injury
Lead sponsor: FUJIFILM Toyama Chemical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-03-21
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A single-arm, multi-center study to verify that knee joint function at 52 weeks after injection of FF-31501 is better than at screening in patients with meniscus tear who are eligible for meniscectomy .


Eligibility criteria: Inclusion Criteria:

1. Patients with suspected meniscal flap tear
2. Patients with knee pain
3. Patients with one or more of the following symptoms

   * Feeling stuck in the knee・Instability of the knee
   * Knee range of motion impairment
   * Knee joint edema
4. Other

Exclusion Criteria:

1. Patients with poor knee alignment
2. Patients who underwent meniscus surgery or platelet rich plasma therapy
3. Patients with or history of knee ligament injury
4. Diabetic patients with poor glycemic control
5. Patients with the following complications and poor general condition

   * Severe cardiovascular disease
   * Severe liver disease
   * Severe renal dysfunction
   * Severe anemia・uncontrolled mental illness
   * Other diseases for which sudden change or worsening of symptoms can be expected during study participation
6. Patients who are pregnant or possibly pregnant and/or breast-feeding, or patients planning to become pregnant during the study period
7. Other

Primary outcomes:
measure: Lysholm score
timeFrame: Screening up to 52 weeks
Secondary outcomes:
measure: Arthroscopic assessment of the meniscus
timeFrame: Meniscus repair up to 52 weeks
measure: Knee injury and osteoarthritis outcome score (KOOS)
timeFrame: Screening up to the Day before injection,4,12,24 and 52 weeks
measure: Numerical Rating Scale (NRS)
timeFrame: Screening up to the Day before injection,4,12,24 and 52 weeks
measure: Kellgren Lawrence
timeFrame: Screening up to 24 and 52 weeks
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Medical corporation keimeikai Juko Osu hospital
city: Fukuoka
country: Japan
facility: Wakamatsu Hospital of the University of OccupationalOC and Environmental Health
city: Mie
country: Japan
facility: Mie Prefectural General Medical Center
city: Tokyo
country: Japan
facility: Tokyo Medical and Dental University Hospital
Study officials:
References:
Clinical trial NCT00316667: Health2006 - an Observational Study of Cardiovascular Disease, Diabetes, Asthma and Allergy
Official title: Health2006 - an Observational Population-based Study of Cardiovascular Disease, Type 2 Diabetes, Asthma and Allergy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Disease
Type 2 Diabetes
Asthma
Hypersensitivity
Osteoporosis
Keywords: epidemiology
risk factors
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
Collaborators: name: Steno Diabetes Center Copenhagen
First posted: 2006-04-21
Enrollment: 3471
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Random sample of citizens living in 11 municipalities in Copenhagen. Age 18-69 years.

Brief summary: The aim is to assess the population prevalence of risk factors for different chronic diseases such as cardiovascular disease, type 2 diabetes, osteoporosis, asthma, and allergy. Risk factors include genetic and serologic biomarkers, questionnaire data on health and lifestyle. There are many hypotheses under study for each research field.

Detailed description: A population-based random sample of persons living in Copenhagen is drawn from the Danish Civil Registration System and invited for a health examination including blood sample drawing, measurement of lung function, serologic and genetic biomarkers, questionnaires on lifestyle and health. The study will form the basis for research within many different areas such as cardiovascular disease, type 2 diabetes, asthma, and allergy.

Eligibility criteria: Inclusion Criteria:

* Persons living in 11 municipalities in Copenhagen

Exclusion Criteria:

* Pregnancy
* Non-Danish citizenship

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Research Centre for Prevention and Health
state: Glostrup
Study officials:
affiliation: Glostrup University Hospital, Copenhagen
name: Allan Linneberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Svendstrup M, Allin KH, Angquist L, Schnohr P, Jensen GB, Linneberg A, Thuesen B, Astrup A, Saris WHM, Vestergaard H, Sorensen TIA. Is abdominal obesity at baseline influencing weight changes in observational studies and during weight loss interventions? Am J Clin Nutr. 2018 Nov 1;108(5):913-921. doi: 10.1093/ajcn/nqy187.
citation: Ahluwalia TS, Troelsen JT, Balslev-Harder M, Bork-Jensen J, Thuesen BH, Cerqueira C, Linneberg A, Grarup N, Pedersen O, Hansen T, Dalgaard LT. Carriers of a VEGFA enhancer polymorphism selectively binding CHOP/DDIT3 are predisposed to increased circulating levels of thyroid-stimulating hormone. J Med Genet. 2017 Mar;54(3):166-175. doi: 10.1136/jmedgenet-2016-104084. Epub 2016 Sep 14.
Clinical trial NCT03830567: Pharmacists Expand Access to Reproductive heaLthcare
Official title: Pharmacists Expand Access to Reproductive Healthcare: Reducing Unintended Pregnancy Through Pharmacist Prescription of Contraception
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraception
Keywords: Hormonal Contraception
Birth Control
Pharmacists
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Laura and John Arnold Foundation
First posted: 2019-02-05
Enrollment: 471
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 51
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women presenting to initiate hormonal contraception at a study pharmacy.

Brief summary: Prospective cohort study of women presenting to initiate hormonal contraception, prescribed by a clinician or pharmacist. Women will be followed for one year to assess contraceptive continuation and unintended pregnancy rates, as well as measures of safety and acceptability.

Detailed description: Direct prescription of hormonal contraception (HC) by pharmacists, without a doctor's visit or medical prescription, is a strategy to improve access to contraception and reduce unintended pregnancy. Oregon is the first state in the nation to implement legislation, as of January 1, 2016, expanding the scope of pharmacists to prescribe short-acting HCs. House Bill (HB) 2879 allows pharmacists to directly prescribe HC including the patch and pill, without a medical prescription. Women over 18 years of age can either initiate or continue HCs with a pharmacist, and women under 18 can continue a prescription.

This prospective cohort study of women presenting to initiate hormonal contraception, prescribed by a clinician or pharmacist, aims to determine contraceptive continuation and incident pregnancy rates between women receiving hormonal contraception from a pharmacist versus other prescriber. Women will be followed for one year to assess contraceptive continuation and unintended pregnancy rates.

Eligibility criteria: Inclusion Criteria:

* Women presenting to initiate hormonal contraception at a study pharmacy

Exclusion Criteria:

* Pregnancy
* Contraindications to hormonal contraception
* Under 18 years of age
* Unable or unwilling to consent

Primary outcomes:
measure: Contraceptive continuation rates
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Maria I Rodriguez, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00124540: Misoprostol for Preventing Postpartum Hemorrhage
Official title: Misoprostol for Preventing Postpartum Hemorrhage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Hemorrhage
Keywords: Misoprostol
Active management
Postpartum hemorrhage
Maternal morbidity
Anemia
Developing countries
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: University of Witwatersrand, South Africa
name: Effective Care Research Unit
name: Family Care International
First posted: 2005-07-28
Enrollment: 1200
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This hospital-based, multicenter, randomized, placebo-controlled trial will assess the effects of misoprostol as part of active management of the third stage of labor on postpartum blood loss, complications, and side effects. Twelve hundred eligible women will receive routine oxytocics (oxytocin 5-10 IU) plus either 400 mcg sublingual misoprostol or placebo during or immediately after delivery. The primary outcome will be measured blood loss of =\>500 mls within one hour after enrollment.


Eligibility criteria: Inclusion Criteria:

* Women who have given birth to 1 or more live-born infants (para 1 or more)
* Vaginal delivery

Exclusion Criteria:

* Refusal or inability to give informed consent
* Delivery regarded as abortion according to local gestational age limits
* Inability to take misoprostol sublingually
* Cesarean section
* Assisted vaginal delivery

Primary outcomes:
measure: Blood loss =>500 mls within one hour after enrollment
Secondary outcomes:
measure: Blood loss =>1000 mls within one hour after enrollment
measure: Mean blood loss after enrollment
measure: Blood transfusion
measure: Hemoglobin level <8 g/dL 24 hours after delivery
measure: Maternal morbidity and mortality
measure: Side effects
Other outcomes:
Locations:
city: Ibadan
country: Nigeria
facility: University College Hospital
city: Johannesburg
country: South Africa
facility: Tembisa Hospital
city: Nelspruit
country: South Africa
facility: Rob Ferreira Hospital
city: Port Elizabeth
country: South Africa
facility: Dora Nginza Hospital
city: Kampala
country: Uganda
facility: Mulago Hospital
Study officials:
affiliation: Effective Care Research Unit, East London Hospital Complex, South Africa
name: Lindeka Mangesi
role: STUDY_DIRECTOR
affiliation: Effective Care Research Unit, Frere Maternity Hospital, East London Hospital Complex
name: G. J. Hofmeyr, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hofmeyr GJ, Fawole B, Mugerwa K, Godi NP, Blignaut Q, Mangesi L, Singata M, Brady L, Blum J. Administration of 400 mug of misoprostol to augment routine active management of the third stage of labor. Int J Gynaecol Obstet. 2011 Feb;112(2):98-102. doi: 10.1016/j.ijgo.2010.08.019. Epub 2010 Dec 4.