louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01983631: The Effect of Whole Body Vibration Training on Neuromuscular Property in Individuals With Ataxia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinocerebellar Ataxia
Keywords: Whole body vibration
Reciprocal inhibition
Spinocerebellar ataxia
voluntary activation level
Lead sponsor: Chang Gung University
Sponsor class: OTHER
First posted: 2013-11-14
Enrollment: 17
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Cerebellum contains ten percent of the total volume of the brain and receives brain, spinal cord and vestibular sensory input. The organization of vestibular and somato-sensory afferent informations are also reported to be impaired in patients with cerebellum dysfunctions. Ataxia and impaired balance control are common symptoms in individuals with spinocerebellar ataxia (SCA). Previous studies have shown that patient with cerebellar damage are usually agonist and antagonist muscle coordination problem. Past studies also found the regulation of reciprocal Ia inhibition was impaired in patients with spinaocerebellar ataxia. In chronic phase, weakness might be developed due to deconditioned. All deficits mentioned above might lead to a decrease functional ability. Therefore, increasing somato-sensory and vestibular input, normalizing the modulation of recriprocal inhibition, and improve muscle strength might be able to improve the functional abilities of individuals with SCA.

Recently, whole body vibration (WBV) has been trained for health groups. Studies showed that WBV training were able to improve muscle strength, balance control, and functional ability. However, there is no evidence showed that whether the whole body vibration training can affect the brain and spinal cord for the regulation of neural circuits. Whether also can affect for maximal voluntary contraction and improve central fatigue. No previous studies that whole body vibration training for SCA.

Therefore, the purpose of this research was to investigate the intracortical facilitation and inhibition, reciprocal Ia inhibition, low frequency depression, maximal voluntary contraction, interpolated twitch technique to compare the different between the SCA and health subject. Also to investigate the short term and long term effect of WBV.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of spinocerebellar ataxia

Primary outcomes:
measure: Muscle twitch force
timeFrame: Baseline, 4 weeks.
measure: Muscle voluntary activity level
timeFrame: Baseline, 4 weeks
measure: Balance
timeFrame: Baseline, 4 weeks
measure: Severity of cerebellar ataxia
timeFrame: Baseline, 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung University
Study officials:
References:
Clinical trial NCT04651231: Punch Trabeculectomy Versus Classic Trabeculectomy
Official title: Values of Releasable Sutures in Punch Trabeculectomy Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma, Open-Angle
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-12-03
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eighty Patients inclusive, randomly distributed for tight flap technique group (forty patients-group A) and for loose flap technique (securing sutures) group (forty patients-group B).
Primary purpose: TREATMENT

Brief summary: Bleb failure is reduced with Punch trabeculectomy procedure. Wide sclerostomy during surgery is wanted but controllable. This can be done with single securing suture, releasable sutures and topical intraoperative mitomycin-c. Average IOP without fluctuation (risk factor) can protect the optic nerve.

Detailed description: This is a prospective randomized study. Patients had uncontrolled glaucoma on maximum tolerated medical therapy including acetazolamide tablets were enrolled in this clinical trial and were randomized to tight flap technique group (group A) and loose flap technique group(group B). Randomization assigned 40 patients to group A and 40 patients to do group B. A total of 80 patients were enrolled in the Study between 2012 and 2014.

During trabeculectomy, Trabecular meshwork and scleral lamellae were excised made an opening with the kelly scleral punch 1.0 mm 3-5 bites. At 12 o'clock 10/0 nylon monofilament stitch was used to close the apex of triangular scleral flap tightly and two releasable stitches were used at the sides of triangular scleral flap in group A. Fig-1 At 12 o'clock 10/0 nylon monofilament stitch was used to secure the edges of the flap at the apex of and two-four releasable stitches were used at the sides of triangular scleral flap in group B. The intraocular pressure and bleb morphology were followed for one year after surgery.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of primary open-angle glaucoma
* Clinical diagnosis of pigmentary glaucoma
* Clinical diagnosis of Pseudophakic glaucoma

Exclusion Criteria:

* high risk factors for failed trabeculectomy must be present e.g. previous failed trabeculectomy surgery and active intraocular infection/ inflammation.
* Clinical diagnosis of aphakic glaucoma was excluded.
* Clinical diagnosis of glaucoma with previous ocular incisional surgery (except for clear cornea cataract surgery) were excluded.

Primary outcomes:
measure: postoperative intraocular pressure (IOP)
timeFrame: one-year follow up
Secondary outcomes:
measure: bleb morphology after surgery
timeFrame: one-year follow up
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03200431: Evaluation of the Influence of Output on Skin Wearing a New Adhesive
Official title: Evaluation of the Influence of Output in Skin Covered by Newly Developed Adhesives
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileostomy - Stoma
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2017-06-27
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose is to investigate the impact real output has on the peristomal skin covered by a newly developed adhesive.


Eligibility criteria: Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Have had a stoma for more than one year
4. Have intact skin on the area used in the evalua-tion
5. Has a stoma with a diameter up to (≤) 35 mm
6. Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist)

Exclusion Criteria:

1. Currently receiving or have within the past 2 month received radio- and/or chemotherapy
2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
3. Are pregnant or breastfeeding
4. Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist)
5. Actively participating in other interventional clinical investigations or have previously participated in this investigation.

Primary outcomes:
measure: Trans epidermal water loss
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Humlebæk
country: Denmark
facility: Coloplast A/S
Study officials:
References:
Clinical trial NCT01978431: Impulsivity and Stimulant Administration
Official title: Impulsivity and Stimulant Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cocaine Dependence
Impulsivity
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2013-11-07
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: Examine the interaction between stimulants, such as cocaine and methylphenidate, and impulsivity.


Eligibility criteria: Inclusion Criteria:

1. age 18 - 50 years,
2. voluntary, written, informed consent,
3. physically healthy by medical history, physical, neurological, ECG, and laboratory examinations,
4. DSM-IV criteria for Cocaine Abuse (305.60) or Cocaine Dependence (304.20)
5. recent street cocaine use in excess of amounts to be administered in the current study,
6. intravenous and/or smoked (crack/ freebase) use,
7. positive urine toxicology screen for cocaine,
8. for females, non-lactating, no longer of child-bearing potential (or agree to practice effective contraception during the study), and a negative serum pregnancy (β-HCG) test.

Exclusion Criteria:

1. Other drug dependence (except nicotine) as determined by urine toxicology or interview
2. \< 1 year of cocaine dependence,
3. a primary major DSM-IV psychiatric diagnosis (schizophrenia, bipolar disorder, etc.), unrelated to cocaine,
4. a history of significant medical (cardiovascular) or neurological illness, ie prior myocardial infarction, current active symptoms of cardiovascular disease / angina, evidence of cocaine-related cardiovascular symptoms, prior arrhythmias or need for cardiovascular resuscitation, neurovascular events such as transient ischemic attacks, stroke, and/or seizures Parameters re: elevations in vital signs are now explicitly specified under "Safety features built into our one-day self-administration paradigm).
5. current use of psychotropic and/or potentially psychoactive prescription medication,
6. seeking treatment for drug abuse/dependence (for experimental cocaine component),
7. physical or laboratory (β-HCG) evidence of pregnancy.
8. current use of any medication (prescription or over-the-counter) determined to cause potential drug interactions by the study physicians.

Primary outcomes:
measure: Mean cocaine inter-infusion interval
timeFrame: 3 hours
Secondary outcomes:
measure: Stop Signal Reaction Time (Impulsivity)
timeFrame: 5 years
measure: Inter-Temporal Choice (Impulsivity)
timeFrame: 5 years
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Connecticut Mental Health Center
state: Connecticut
Study officials:
References:
Clinical trial NCT01568931: Local Thrombolytics Before Thrombectomy in STEMI
Official title: Local Delivery of thrombolytIcs Before Thrombectomy in patientS With ST-elevatiOn myocardiaL Infarction Undergoing Primary percuTaneous Coronary interventION - The DISSOLUTION Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: thrombectomy
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2012-04-02
Enrollment: 100
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: Background Prompt reperfusion with percutaneous coronary intervention (PCI) in the setting of ST-elevation myocardial infarction (STEMI) improves clinical outcomes through salvage of myocardial tissue.

Although the use of thrombus aspiration with PCI can result in improved rates of normal epicardial flow and myocardial perfusion, several unmet needs remain.

Purpose The purpose of this trial will be to evaluate the hypothesis that local delivery of thrombolytics vs. saline infusion prior to thrombus aspiration and PCI is safe and effective in patients with STEMI.

Detailed description: The study will select patients with ST-elevation myocardial infarction (STEMI) with angiographic evidence of massive thrombosis in the culprit artery undergoing manual thrombectomy followed by primary percutaneous coronary intervention (PCI).

Patients will be randomized to receive local bolus of 200,000 units urokinase or saline solution

Eligibility criteria: Inclusion Criteria:

* ST-elevation myocardial infarction
* angiographic evidence of massive thrombosis in the culprit artery
* Indication to manual thrombectomy followed by primary percutaneous coronary intervention (PCI)
* Able to understand and willing to sign the informed CF

Exclusion Criteria:

* Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT

Primary outcomes:
measure: Outcomes at 30 days
timeFrame: Up to 30 days
Secondary outcomes:
measure: Myocardial reperfusion after Primary CI
timeFrame: Up to 90 minutes after Primary PCI
measure: Left ventricular remodeling
timeFrame: Up to 1 year after Primary PCI
measure: 5-year MACE
timeFrame: Up to 5 years after Primary PCI
Other outcomes:
Locations:
Study officials:
affiliation: University Sapienza
name: Cesare Greco, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06713031: Medial Enhancement Technique for the Treatment of Old Femoral Neck Fractures
Official title: Prospective, Multicenter, Randomized Controlled Clinical Study of Medial Enhancement Technique for the Treatment of Old Femoral Neck Fractures
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fracture of Neck of Femur
Keywords: cannulated compression screws with iliac bone graft
Medial enhancement technique with iliac bone graft
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2024-12-03
Enrollment: 400
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: A prospective, multi-center, randomized controlled study was conducted to validate the safety and effectiveness of employing the medial augmentation technique (incorporating the dynamic condylar screw and medial support plate) supplemented with bone grafting for the treatment of old femoral neck fractures.


Eligibility criteria: Inclusion Criteria:

1. Age \>= 18 years, gender not specified;
2. Patients with femoral neck fractures who have not undergone surgery for more than 3 weeks, or patients with persistent non-union following internal fixation of femoral neck fractures;
3. Have indications for internal fixation surgery for femoral neck fractures and are able to tolerate the surgery;
4. Participants or their legal representatives are informed about the nature of this study and agree to participate.

Exclusion Criteria:

1. Participants who have not reached the primary endpoint of other drug, biological agent, or medical device clinical trials prior to enrollment;
2. Known history of hypersensitivity to one or more implanted materials by the patient;
3. Judged by the investigator as physically frail or unable to tolerate surgery due to other systemic diseases;
4. Active infectious foci in the hip joint or other parts of the body, as judged by the investigator;
5. Diagnosed with metabolic bone disease, radiation-induced bone disease, etc.;
6. Severe hip contracture deformity or severe muscle weakness that has been immobilized in functional position for a long time and painless;
7. Suffering from inflammatory arthritis, such as rheumatoid arthritis, systemic lupus erythematosus arthritis, ankylosing spondylitis, etc.;
8. Patients who lack the mental capacity or understanding to meet the requirements of participating in the study, or are difficult to cooperate with;
9. Other situations where the investigator deems the participant unsuitable for inclusion.

Primary outcomes:
measure: Fracture healing rate
timeFrame: 1 year
Secondary outcomes:
measure: Femoral head necrosis
timeFrame: 1 year
measure: Harris score
timeFrame: 1 year
measure: VAS score
timeFrame: 1 year
measure: Complications
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hosptial
Study officials:
References:
Clinical trial NCT01236131: The Role of Novel Organisms in Acute Endometritis
Official title: Characterization of Novel Organisms in the Genital Tract of Women With PID and Determination of Their Association With Endometritis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Inflammatory Disease
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2010-11-07
Enrollment: 480
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Endometrial biopsy samples from women participating in University of Pittsburgh IRB PRO10010112 and PRO10010159

Brief summary: The goal of this project is to identify the microorganisms present in the endometrial samples obtained from women with or without evidence of endometritis using a combination of culture methods, rRNA sequencing and whole genomic sequencing. The overarching aim of these studies is to identify the etiology of endometritis. The investigators will define the role of fastidious anaerobic microorganisms in the etiology of PID, and assess whether antibiotic treatment regimens used for the treatment of PID have activity against the novel organisms linked with pelvic infections.


Eligibility criteria: Inclusion Criteria:

* This is a laboratory research study involving the use of biologic specimens only.
* Specimens (endometrial biopsy samples) collected from subjects who meet the inclusion criteria for PRO10010159 and PRO10010112 will be utilized for this study.

Exclusion Criteria:

* Specimens (endometrial biopsy samples) that are collected from subjects enrolled in PRO10010159 and PRO10010112 that are insufficient will not be included in this study.

Primary outcomes:
measure: Identification of Novel Organsims from PRO10010159
timeFrame: 12 months after participant enrollment in PRO10010159
measure: Identification of Novel Organisms from PRO10010112
timeFrame: 30 days after participant enrollment in PRO10010112
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Magee-Womens Research Institute
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Sharon L Hillier, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03659331: A Controlled Study of Potential Therapeutic Effect of Oral Zinc in Manifesting Carriers of Wilson Disease
Official title: A Controlled Study of Potential Therapeutic Effect of Oral Zinc in Manifesting Carriers of Wilson Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Wilson Disease
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2018-09-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A model based on the assumption that at least 50 subjects will be recruited, and assuming that 50% of the patients will have a significant reduction of liver enzymes
Primary purpose: TREATMENT

Brief summary: The assumption is that in some of the carriers, the increase in enzymes reflects tissue damage due to excess copper. The reduction of the amount of copper absorbed will decrease excess copper in the liver, which will result in a decrease in the level of liver enzymes. Zinc causes the induction of metalothionines in the intestine, which in turn prevents absorption of copper from the digestive system. Zinc administration in Wilson's patients causes the depletion of copper deposits and constitutes one of the cornerstones in the treatment of this disease.

Detailed description: The research group is composed of patients over the age of 18 referred for unexplained elevation of liver enzymes and carry a single mutation in the ATP7B gene. After a washout period of 3 months these patients will be re-checked for liver enzymes and if high will receive zinc therapy at a dose of 300 mg / day for 6 months, after which the liver enzymes will be checked again.

Eligibility criteria: Inclusion Criteria:

patients over the age of 18 unexplained elevation of liver enzymes patients that carry a single mutation in the ATP7B gene.

-

Exclusion Criteria:

na

Primary outcomes:
measure: measurement of liver enzymes in blood tests
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The Institute of Human Genetics, Sheba Medical Center, Israel
name: Elon Pras, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01735331: Vascular Endothelial Growth Factor Levels at Hysteroscopic Biopsies Which Taken From Recurrent Pregnancy Loss
Official title: Vascular Endothelial Growth Factor Levels at Hysteroscopic Biopsies Which Taken From Recurrent Pregnancy Loss
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recurrent Pregnancy Loss Without Current Pregnancy
Keywords: Vascular endothelial growth factor, Recurrent Pregnancy Loss
Lead sponsor: Bagcilar Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2012-11-28
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients with Recurrent Pregnancy Loss

Brief summary: The aim of this study is determine vascular endothelial growth factor levels and angiogenesis/vascularity from hysteroscopic endometrial biopsies which taken from patients who has Recurrent Pregnancy Loss.The endometrial vascular endothelial growth factor levels will be measured by immunohistochemical staining methods due to office hysteroscopic endometrial biopsy after the menstruation at follicular phase of menstrual cycle.

Detailed description: This study is a prospective,observational,single-center study.Ethical approval was obtained from the Institutional Review Board.This study will be completed 30 patients with Habitual Abortus.

Endometrial vascular endothelial growth factor levels will be measured using Flk-1 / Kinase Domain Receptor / Vascular endothelial growth factor receptor-2, Ab-1 (Rabbit PAb), Vascular Endothelial Growth Factor (VEGF) Ab-7 (VG1), Cluster of Differentiation 34 (Endothelial Cell Marker) Ab-1 (QBEnd/10), Vascular endothelial growth factor receptor-1 (N-term) (FLT1) antibody kits. All assays will be performed according to the manufacturer's instructions.

Eligibility criteria: Inclusion Criteria:

* Patients with Recurrent Pregnancy Loss who accept to join the study.

Exclusion Criteria:

* Patients whose age of \<18 and \>45
* Patients with have any pregnancy.

Primary outcomes:
measure: The primary outcome measure of this study is to determine endometrial vascular endothelial growth factor levels in patient with Recurrent Pregnancy Loss
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bagcilar Training and Research Hospital
Study officials:
affiliation: Bagcilar Training and Research Hospital,Istanbul,Turkey.
name: TANER A. USTA, M.D.
role: PRINCIPAL_INVESTIGATOR
References: