louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00406822: OculusGen-Glaucoma Historical Control Study in Taiwan
Official title: Study of the Safety and Effectiveness of the OculusGen Collagen Matrix Implant as an Aid in Glaucoma Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Glaucoma
Keywords: Glaucoma
collagen matrix
OculusGen
trabeculectomy
tissue engineering
Lead sponsor: Pro Top & Mediking Company Limited
Sponsor class: INDUSTRY
First posted: 2006-12-04
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the OculusGen Collagen Matrix are effective and safe to implant as an aid of glaucoma surgery.

Detailed description: OculusGen® Collagen Matrix is a porous, scaffold matrix. It is to be implanted on the top of the scleral flap and beneath the conjunctiva and Tenon's capsule at the end of trabeculectomy. The pores in the scaffold matrix range from 20 to 200µm, a size that is suitable for fibroblasts to grow randomly, through the body of the matrix without causing scarring. The space occupied by the collagen matrix scaffold creates room for the development of a filtration bleb. Immediately after implantation, the collagen matrix is absorbed with the aqueous humor that bring a certain pressure press on the top of scleral flap which makes the dynamic balance for the aqueous system to keep the IOP in the right side. The collagen matrix is bio-degraded within 90 days and will leave a physiologic space for the filtration bleb to facilitate control of intraocular pressure (IOP).

Eligibility criteria: Subject inclusion criteria:

1. Age 18 years or over.
2. At least one eye diagnosed with glaucoma and receiving maximally tolerated medical therapy.
3. Subject able and willing to cooperate with investigation plan.
4. Subject able and willing to complete postoperative follow-up requirements.
5. Subject willing to sign informed consent form.

Subject exclusion criteria:

1. Have allergic reactions to collagen
2. Subject is taking anticoagulation and/or the physician does not suggested to stop taking the medication
3. Normal tension glaucoma patient
4. Subject has one eye received OculusGen™ implantation
5. Subject who been diagnosed infection with the operation eye
6. Subject with anterior chamber abnormality
7. Subject with steroid glaucoma

Primary outcomes:
measure: the effectiveness via the reduction of IOP
timeFrame: 180 day
Secondary outcomes:
measure: the safety via the incidence of complications and adverse events.
timeFrame: 180day
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Chang Gung Memorial Hospital -Taipei Branch
Study officials:
affiliation: Chang Gung Memorial Hospital-Taipei Branch
name: Henry SL Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hsu WC, Spilker MH, Yannas IV, Rubin PA. Inhibition of conjunctival scarring and contraction by a porous collagen-glycosaminoglycan implant. Invest Ophthalmol Vis Sci. 2000 Aug;41(9):2404-11.
Clinical trial NCT00972322: Pharmacokinetics and Pharmacodynamics of MK-8245 in Participants With Type 2 Diabetes (MK-8245-012)
Official title: A Placebo-Controlled Multiple Dose Study to Evaluate the Pharmacokinetics and Pharmacokinetics of MK-8245 in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-09-04
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the safety, tolerability, pharmacokinetics, and glucose lowering activity of MK-8245 in participants with type 2 diabetes. The primary hypothesis of the study is that after 4 weeks of treatment, MK-8245 produces a greater reduction in 24 hour weighted mean glucose (WMG) from baseline than placebo.


Eligibility criteria: Inclusion Criteria:

* Subject has a diagnosis of type 2 diabetes and is being treated with diet and exercise alone, a single oral anti-hyperglycemic agent or a combination of two oral anti-hyperglycemic agents
* Subject is willing to follow a weight-maintaining diet and exercise program during the study
* Subject is a nonsmoker or is willing to limit smoking to 10 cigarettes per day while in the clinical research unit

Exclusion Criteria:

* Subject has a history of stroke, chronic seizures, or major neurological disorder
* Subject has a history of cancer, except certain skin and cervical cancers or cancer that was successfully treated 10 or more years prior to screening
* Subject has a history of type 1 diabetes
* Subject has used contact lenses within the last 6 months
* Subject has used any lipid-lowering therapy in the last 3 months, except statins, Zetia, or Vytorin
* Subject has more than 3 alcoholic beverages per day
* Subject has more than 6 servings of caffeine a day
* Subject has participated in a previous MK8245 study

Primary outcomes:
measure: Change From Baseline in the 24-hour Weighted Mean Glucose (WMG)
timeFrame: Baseline and Day 28
measure: Number of Participants Who Experienced Serious or Non-serious Adverse Events
timeFrame: Up to Day 31
measure: Number of Participants Discontinuing Study Drug Due to an AE
timeFrame: Up to Day 28
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00272922: Randomized, Prospective Controlled Trial of Paraesophageal Hernia Repair With Small Intestinal Submucosa (SIS)
Official title: Randomized, Prospective Controlled Trial of Paraesophageal Hernia Repair With Small Intestinal Submucosa (SIS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hernia
Paraesophageal Hernia
Keywords: Biomaterials
Paraesophageal Hernia
Laparoscopy
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2006-01-09
Enrollment: 150
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 randomized study is to determine whether a type of mesh derived from a layer of pig small intestine (SIS) is of benefit in treating paraesophageal hernias versus standard surgical suture repair.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Documented symptomatic paraesophageal hernia
* Ability to participate in follow-up evaluation
* Has a telephone
* Free of cognitive or speech impairment

Exclusion Criteria:

* Patients requiring intra-operative conversion to an open procedure
* Unable to close the crura primarily
* Short esophagus that requires the surgeon to perform a lengthening procedure
* Previous operation of the esphagus or stomach
* Associated gastrointestinal diseases that require extensive medical or surgical intervention that might interfere with quality of like assessment
* Intraoperative full-thickness perforation of the esophagus
* Emergent operation for acute volvulus
* Ineffective peristalsis defined as average amplitude of peristalsis less than 30 mmHg or \< 70% propagation of peristaltic waves in the distal esophagus

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Brant K Oelschlager, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02885922: The Effects of add-on Anti-diabetic Drugs in Type 2 Diabetic Patients
Official title: The Effects of add-on Anti-diabetic Drugs on Inflammation and Energy Homeostasis in Type 2 Diabetic Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hyperglycemia
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2016-09-01
Enrollment: 6000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 2 diabetic patients in Taichung Veterans General Hospital

Brief summary: Recently, there are some new classes of anti-diabetic drugs availible in Taiwan. In this study, we will observe the change in inflammation and energy homeostasis in type 2 diabetic outpatient, who receiving a new anti-diabetic drugs.

Detailed description: Recently, there are some new classes of anti-diabetic drugs availible in Taiwan. However, the effects of these anti-diabetic drugs should be further evaluated. Specially, the effects on inflammation and energy homeostasis are still not well assessed. In this study, we will observe the change in inflammation and energy homeostasis in type 2 diabetic outpatient, who receiving a new anti-diabetic drugs.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetic outpatient

Exclusion Criteria:

* Refusal of anti-diabetic drugs
* Preganacy

Primary outcomes:
measure: HbA1c
timeFrame: 3 months
Secondary outcomes:
measure: Brain-Derived Neurotrophic Factor (BDNF)
timeFrame: 3 months
measure: Body-composition
timeFrame: 3 months
measure: Fasting glucose
timeFrame: 3 months
measure: Hypoglycemia
timeFrame: 3 months
measure: Vascular Cell Adhesion Molecule 1 (VCAM-1)
timeFrame: 3 months
measure: Ankle-Brachial Index (ABI)
timeFrame: 12 months
measure: Orexin-A
timeFrame: 3 months
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: outpatient clinic of the Division of Endocrinology and Metabolism in Taichung Veterans General Hospital
Study officials:
affiliation: Taichung Veterans General Hospital
name: I-Te Lee, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05088122: Hormonal Effect of Different Menstrual Phases on Dynamic Balance in Postpubertal Females
Official title: Hormonal Effect Of Different Phases Of Menstrual Cycle On Postural Stability In Postpubertal Females: A Cross Sectional Repeated Measure Design
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Menstrual Cycle
Keywords: Sex hormones, Postural stability, Menstrual cycle.
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-10-21
Enrollment: 36
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Thirty-six, healthy postpubertal females , their ages will be ranged from 16-25 and BMI will be ranged from 18-27kg/m2, with regular menstrual cycle and with no any health condition that can affect the balance performance

Brief summary: High rate of injuries detected during certain periods of menstrual cycle, raised the suggestion of the effecacy of the female sex hormones on soft tissue and neuromuscular control with subsequent deterioration of postural stability and high injury prevalence in post pubertal females so the aim of the present study is to investigate the effect of female sex hormones on postural stability in post pubertal females.

Detailed description: Thirty-six post pubertal females will participate in this study. They will be selected from students and graduates of Faculty of Physical Therapy, Deraya University and they will be assigned into one group. Postural stability assessment will be carried out throughout three menstrual cycle phases, early follicular, ovulation and mid luteal phases by Biodex balance system. The timing of menstrual cycle phases will be determined by measuring serum estradiol and progesterone level. The exact time of ovulation will be determined by urine lutenizing hormone ovulatory strip test.

Eligibility criteria: Inclusion Criteria:

1. All females will be virginal.
2. Their ages will range from 15-25 years.
3. Their body mass index (BMI) will range from 18-27 kg/m2.
4. All females will have regular menstrual cycle within average of 28 days.

Exclusion Criteria:

1. Females having menstrual irregularity.
2. Use of oral contraceptives or any hormonal treatment in the previous six months before participate in this study.
3. History of lower extremity injury, surgery or pain during ADL.
4. Females having any vestibular problems , otitis media, labyrinthitis or any inner ear problems that affect balance.

Primary outcomes:
measure: serum estradiol level
timeFrame: two months
measure: Anetro-posterior stability index
timeFrame: two months
measure: Medio-lateral stability index
timeFrame: two months
measure: Overall stability index
timeFrame: two months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02681939: Effect of Tulsi (Ocimum Sanctum) on Biochemical Parameters in Young Overweight and Obese Subjects
Official title: Effect of Supplementation of Tulsi (Ocimum Sanctum Linn.) on Metabolic Parameters and Liver Enzymes in Young Overweight and Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Lead sponsor: All India Institute of Medical Sciences, Bhubaneswar
Sponsor class: OTHER
First posted: 2016-02-15
Enrollment: 30
Sex: ALL
Minimum age (years): 17
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study to investigate the effect of Tulsi (Ocimum sanctum Linn.) on metabolic and biochemical parameters in young overweight and obese subjects. Thirty overweight/obese volunteers will be divided into two groups. The first group will receive no intervention. The second group will be supplemented with one capsule of Tulsi orally every morning and evening in empty stomach for 60 days. The metabolic parameters and liver enzymes will be evaluated before and after the intervention.

Detailed description: This is a randomized, parallel group, open label pilot study to investigate the effect of Tulsi (Ocimum sanctum Linn.) on metabolic and biochemical parameters in young overweight and obese subjects. Thirty overweight/obese volunteers will be divided into two groups. The first group will receive no intervention. The second group will be supplemented with one capsule of Tulsi orally every morning and evening in empty stomach for 60 days. The metabolic parameters and liver enzymes will be evaluated before and after the intervention.

Eligibility criteria: Inclusion Criteria:

* Overweight/obese volunteers of both genders from age 17 to 30 years

Exclusion Criteria:

* Addiction to tobacco and/or alcohol.
* Not on drugs like fluoroquinolones, anticonvulsants, antihypertensives, corticosteroids, hormonal contraceptives, hypolipidemic agents, anti psychotics, protease inhibitors and isotretinoin.
* Not suffering from liver disease, malabsorption, nephrotic syndrome, thyroid disorder, allergy or any other chronic disease.

Primary outcomes:
measure: Serum lipid profile
timeFrame: 60 days
Secondary outcomes:
measure: Fasting plasma glucose
timeFrame: 60 days
measure: Fasting plasma insulin
timeFrame: 60 days
measure: Serum liver enzymes
timeFrame: 60 days
measure: Insulin resistance
timeFrame: 60 days
measure: Body mass index
timeFrame: 60 days
Other outcomes:
Locations:
city: Bhubaneswar
country: India
facility: All India Institute of Medical Sciences, Bhubaneswar
state: Odisha
Study officials:
affiliation: All India Institute of Medical Sciences, Bhubaneswar
name: Sushil Ch Mahapatra, MBBS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02693639: Prediction Value of PANX1 in Infection Post Liver Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infection
Keywords: PANX1
Infection
Liver transplantation
Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Chinese Academy of Sciences
First posted: 2016-02-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients underwent liver transplantation.

Brief summary: The purpose of this study is to determine prediction value of PANX1 expression in infection post liver transplantation.


Eligibility criteria: Inclusion Criteria:

* patients underwent liver transplantation.

Exclusion Criteria:

* re-transplantation
* multiorgan transplantation
* living donors or split-liver donors liver transplantation

Primary outcomes:
measure: Post-transplant infections
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03892239: The Effectiveness of a Running-related Injury Prevention Program in Runners
Official title: The Effectiveness of a Running-related Injury Prevention Program in Brazilian Runners: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Running-related Injuries
Lead sponsor: Universidade Cidade de Sao Paulo
Sponsor class: OTHER
First posted: 2019-03-27
Enrollment: 530
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Running is effective in increasing levels of physical activity and promotes a number of beneficial health effects. However, running can lead to running- related injuries (RRI). In theory, such injuries can be avoided with the implementation of prevention programs. But in practice, there is a paucity of prevention programs that are effective in reducing the risk of RRIs. In a previous study, the investigators developed an RRI prevention program using the Intervention Mapping framework. The RRI prevention program was named RunIn3. The present study will evaluate the effectiveness of the RunIn3 RRI prevention program.

Objective: To investigate the effectiveness of an RRI prevention program (i.e., RunIn3).

There will be recruited 530 runners of the state of São Paulo aged 18 years or older. After inclusion, participants will be randomly assigned and allocated in two groups: (1) intervention group, which will be the target of the implementation of the RunIn3 prevention program; and (2) control group, which will receive a minimal intervention (i.e., feedback based on surveillance).


Eligibility criteria: * Running experience of at least three months;
* Residents of the state of São Paulo;
* No running-related injury (RRI) at baseline;
* No history of RRI in the past three months.

Primary outcomes:
measure: Running-related injuries (RRI)
timeFrame: After 12 months from baseline
Secondary outcomes:
measure: Behaviour
timeFrame: After 12 months from baseline
measure: Costs
timeFrame: After 12 months from baseline
measure: Incremental cost-effectiveness ratio (ICER)
timeFrame: After 12 months from baseline
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Universidade Cidade de São Paulo (UNICID)
Study officials:
affiliation: Universidade Cidade de São Paulo (UNICID)
name: Caio S Vallio, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Cidade de São Paulo (UNICID)
name: Luiz Hespanhol, PhD
role: STUDY_CHAIR
References:
citation: Barros PM, Vallio CS, Oliveira GM, Miyamoto GC, Hespanhol L. Cost-effectiveness and implementation process of a running-related injury prevention program (RunIn3): Protocol of a randomized controlled trial. Contemp Clin Trials Commun. 2021 Jan 20;21:100726. doi: 10.1016/j.conctc.2021.100726. eCollection 2021 Mar.
Clinical trial NCT01731639: Motile Sperm Organelle Morphology Examination (MSOME) Influence on Intracytoplasmic Sperm Injection (ICSI) Outcomes in Infertile Couples
Official title: The Influence of Motile Sperm Organelle Morphology Examination on ICSI Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Lead sponsor: Sapientiae Institute
Sponsor class: OTHER
First posted: 2012-11-22
Enrollment: 72
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A new technique based on the motile sperm organelle morphology examination (MSOME) at a magnification of at least ×6000 has been developed. The MSOME assesses the nucleus, for both shape and chromatin content, which is the most important sperm organelle in influencing intracytoplasmic sperm injection (ICSI) outcomes.

Detailed description: Sperm morphology has been described as one of the major determinants of male in vitro fertility. However, the standard morphology evaluation on random stained cells from the ejaculate is of limited value during ICSI. Current research is directed towards the dysmorphisms of the sperm head.A new technique based on the motile sperm organelle morphology examination (MSOME) at a magnification of at least ×6000 has been developed. The MSOME assesses the nucleus, for both shape and chromatin content, which is the most important sperm organelle in influencing ICSI outcomes. The goals for this study are to identify whether there is a connection between morphologic sperm normalcy under high magnification and (i) semen analysis according to the new World Health Organization (WHO) reference values and (ii) ICSI outcomes.

Eligibility criteria: Inclusion Criteria:

* Couples undergoing ICSI as result of male factor or tubal factor or unexplained infertility
* Women with regular menstrual cycles of 25-35 days
* Women with normal basal follicle stimulating hormone (FSH) and luteinizing hormone (LH) levels
* Women with body mass index (BMI) less than 30 kg/m2
* Women with both ovaries and intact uterus

Exclusion Criteria:

* Women with polycystic ovaries syndrome
* Women with endometriosis
* Women with gynaecological/medical disorders
* Couples with any sexually transmitted disease
* Women who had received any hormone therapy for less than 60 days preceding the study

Primary outcomes:
measure: Pregnancy rates
timeFrame: 1 month
Secondary outcomes:
measure: Implantation rates
timeFrame: 1 month
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Sapientiae Institute
Study officials:
affiliation: Sapientiae Institute
name: Edson Borges Jr., MD., PhD
role: PRINCIPAL_INVESTIGATOR
References: