louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01074827: Improving Gait in Multiple Sclerosis (MS) - Strength Training or Treadmill Walking?
Official title: Strength Training or Treadmill Walking? A Randomized Control Study on the Effect on Gait in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Walking ability
Strength
Balance
Treadmill walking
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
name: Helse Midt-Norge
First posted: 2010-02-24
Enrollment: 28
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 objective of this study is to evaluate the effect of strength training for the lower extremities and treadmill training on walking ability in persons with Multiple Sclerosis. The study is a randomized control trial with two groups and the intervention is 8 weeks of intensive strength training or treadmill walking. Primary outcome measure is walking ability, secondary outcome measures are balance, work economy and strength.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with Multiple Sclerosis,classified as relapsing remitting,or primary/secondary progressive
* Expanded Disability Status Scale (EDSS)score of ≤ 6
* Reduced walking ability (subjectively experienced)

Exclusion Criteria:

* persons with a level of ataxia, clinically assessed, that would affect their ability to perform the training.
* spasticity requiring stretching og treatment with baclofen.
* Other, not MS-related, conditions affecting walking ability.

Primary outcomes:
measure: Walking ability
timeFrame: 8 weeks
Secondary outcomes:
measure: Strength
timeFrame: 8 weeks
measure: Work economy O2
timeFrame: 8 weeks
measure: Balance
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs Hospital
Study officials:
affiliation: St. Olavs Hospital
name: Siri M, Brændvik
role: STUDY_CHAIR
References:
citation: Braendvik SM, Koret T, Helbostad JL, Loras H, Brathen G, Hovdal HO, Aamot IL. Treadmill Training or Progressive Strength Training to Improve Walking in People with Multiple Sclerosis? A Randomized Parallel Group Trial. Physiother Res Int. 2016 Dec;21(4):228-236. doi: 10.1002/pri.1636. Epub 2015 Jun 25.
Clinical trial NCT02879227: Radiochemotherapy in Elderly Patients With Oesophagus Cancer
Official title: Phase II of Radiochemotherapy in Elderly Patients With Oesophagus Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophagus Cancer
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-08-25
Enrollment: 23
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase II study of radiochemotherapy for elderly patients with oesophagus cancer.

Detailed description: Phase II study of radiochemotherapy for elderly patients with oesophagus cancer with Radiotherapy = 50 Gy, 2Gy/f ans chemotherapy with 2 arms arm Cisplatin = Cisplatin 75mg/m2 J1J22 or arm Oxaliplatine = oxaliplatine 85mg/m2 every 2 weeks.

Eligibility criteria: Inclusion Criteria:

* patients aged 75 or more with oesophagus cancer (squamous or adenocarcinoma), fit to treat

Exclusion Criteria:

* previous radiotherapy
* no fit to treat

Primary outcomes:
measure: Feasibility of treatment: Number of patients with completed treatment
timeFrame: 6 weeks after end of the radiochemotherapy
Secondary outcomes:
measure: Tumoral response
timeFrame: 6 weeks after end of the radiochemotherapy
measure: Quality of life
timeFrame: 6 weeks after end of the radiochemotherapy
measure: Quality of life
timeFrame: 6 weeks after end of the radiochemotherapy
Other outcomes:
Locations:
Study officials:
References:
citation: Servagi-Vernat S, Bosset M, Crehange G, Buffet-Miny J, Puyraveau M, Maingon P, Mercier M, Bosset JF. Feasibility of chemoradiotherapy for oesophageal cancer in elderly patients aged >or=75 years: a prospective, single-arm phase II study. Drugs Aging. 2009;26(3):255-62. doi: 10.2165/00002512-200926030-00006.
citation: Servagi-Vernat S, Crehange G, Roullet B, Guimas V, Maingon P, Puyraveau M, Bosset JF. Phase II Study of a Platinum-Based Adapted Chemotherapy Regimen Combined with Radiotherapy in Patients 75 Years and Older with Esophageal Cancer. Drugs Aging. 2015 Jun;32(6):487-93. doi: 10.1007/s40266-015-0275-8.
Clinical trial NCT01953627: Laparoscopic Gynecologic Surgery With Robotic Assistance System Kymerax® : Pilot Study
Official title: Laparoscopic Gynecologic Surgery With Robotic Assistance System Kymerax® : Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gynecological Surgery
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2013-10-01
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Laparoscopic robotic surgery (LSM) seems to increase quality of surgery. Diffusion of LSM is limited by cots of the only available system today. Kymerax® is a cheaper new system of LSM.

Aim : To evaluate feasibility of laparoscopy with Kymerax® system in different laparoscopic procedures in gynecology.

Material and methods : Observational study. Inclusion criteria were : patient requiring laparoscopic procedure in gynecology who give informed consent. The investigators evaluate procedures routinely performed by laparoscopy in gynecology.

Hypothesis : Procedures performed routinely in gynecology were feasible with Kymerax® system.


Eligibility criteria: Inclusion Criteria:

* Patient requiring a following surgical procedure realized usually by coelioscopy:

Total hysterectomy or inter annexielle for mild or neoplastic pathology Promontofixation for genital prolapse Annexectomie or ovarian kystectomie for ovarian pathology Pelvic or lombo-aortic cleaning out for uterine cancer Tubaire Salpingectomie for pathology Rectovaginale partition Exérèse hurts of endometriosis

Exclusion Criteria:

* Patient refusing to participate in the study
* Patient understanding French.
* Minor waits

Primary outcomes:
measure: assessment of Kymerax systemerax
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: BERNARD BELAIGUES
role: STUDY_DIRECTOR
affiliation: AP HM
name: aubert AGOSTINI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01523327: Study of Association Between Maternal Uric Acid , Maternal and Fetal Outcome in Pregnant Women With Hypertension
Official title: Association of Maternal Uric Acid With Maternal Condition and Fetal Outcome in Pregnant Women With Hypertension
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Uric Acid and Hypertension in Pregnancy
Keywords: Uric acid
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2012-02-01
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study will include 80 pregnant ladies with hypertension admitted to the maternity ward of the hospital who will be divided into two groups according to their uric acid level.

Brief summary: Association of maternal uric acid with maternal condition and fetal outcome in pregnant women with hypertension.

Detailed description: Association of maternal uric acid with maternal condition(renal function,liver function,...ect.) and fetal outcome(birth weight,APGER score) in pregnant women with hypertension.

Eligibility criteria: Inclusion Criteria:

* Age:18-40 years old
* Gestational age:28-42 weeks gestation singleton pregnancy of living fetus
* Non smoker

Exclusion Criteria:

* women who refuse the study
* Any medical or obstetric disorders especially D.M.,renal disease,hepatic, cardiac disorders or gout arthritis, other than hypertension if present.
* Previously elevated uric acid level.
* Hemolytic or sickle cell anemia,urinary tract infection.
* Use of diuretics or anti-inflammatory drugs.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams maternity hospital
Study officials:
affiliation: Ain Shams Maternity Hospital
name: Mohamed Saeedeldin Elsafty, assistant lecture
role: STUDY_DIRECTOR
References:
citation: MATSELIUKH BP. [TRANSMISSION OF CERTAIN BIOCHEMICAL PROPERTIES IN ACTINOMYCETES BY MEANS OF DNA UNDER CONDITIONS OF HETEROTRANSFORMATION]. Mikrobiol Zh. 1963;25:3-6. No abstract available. Russian.
citation: Paula LG, da Costa BE, Poli-de-Figueiredo CE, Antonello IC. Does uric acid provide information about maternal condition and fetal outcome in pregnant women with hypertension? Hypertens Pregnancy. 2008;27(4):413-20. doi: 10.1080/10641950801955709.
Clinical trial NCT02822027: Intravenous Immunoglobin Transfusion in Preterm Infants With Encephalopathy of Prematurity
Official title: Intravenous Immunoglobin Transfusion in Preterm Infants With Encephalopathy of Prematurity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preterm Infants
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
First posted: 2016-07-04
Enrollment: 20
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Infection and inflammation is related to increased encephalopathy of prematurities.

Detailed description: Animal studies have verified intravenous immunoglobin can reduce brain injury. However, no studies in preterm infants were reported.

Eligibility criteria: Inclusion Criteria:

* preterm infants with encephalopathy

Exclusion Criteria:

* refuse the participate in the trial

Primary outcomes:
measure: structural changes of brain injury
timeFrame: 100-days
measure: functional changes of brain injury
timeFrame: 100-days
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Department of Pediatrics,Daping Hospital
state: Chongqing
Study officials:
References:
Clinical trial NCT06935227: Steri-Strip Tape Use in Unilateral Ectropion Surgery
Official title: Postoperative Outcomes of Steri-Strip Surgical Tape Use in Unilateral Ectropion Surgery: A Parallel-Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ectropion
Lead sponsor: Sanitas University
Sponsor class: OTHER
First posted: 2025-04-20
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Currently, the incidence of involutional and chronic eyelid disorders, such as ectropion, has been increasing, as human life expectancy has risen worldwide (more than 600 million people are aged ≥ 60 years). Ectropion is a common eyelid malposition that causes visual morbidity. It is characterized by eversion of the eyelid margin and has multiple etiologies.

Steri-Strip tapes have been used in some ophthalmologic procedures, such as blepharoplasties, where they help prevent infections by acting as a barrier method, are resistant enough to reduce the risk of wound dehiscence, simplify postoperative care, and allow for proper eyelid fissure closure. Their use has been recommended in patients with facial paralysis to prevent keratitis or exposure ulcers. However, current evidence is limited, as their use has only been documented in case series and letters to the editor. Therefore, a randomized controlled clinical trial is proposed to evaluate the postoperative outcomes of Steri-Strip tape use in unilateral ectropion surgery compared to standard postoperative management.

Detailed description: This study will compare the use of Steri-Strip tape in unilateral ectropion surgery with standard postoperative care to assess cosmetic and functional outcomes in the adult population. Participants will be followed up at 8 and 30 days after surgery.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or older who are scheduled to undergo unilateral ectropion surgery.

Exclusion Criteria:

* Underlying conditions associated with skin hyperlaxity, such as cutis laxa and Ehlers-Danlos syndrome.
* Skin diseases that predispose to cicatricial ectropion, such as ichthyosis, scleroderma, and psoriasis.
* Paralytic ectropion.
* Current use of oral isotretinoin.

Primary outcomes:
measure: Eyelid position
timeFrame: Measurements will be taken in the immediate postoperative period (within the first hour) and at 30 days following surgery.
Secondary outcomes:
measure: Surgical wound closure
timeFrame: This will be assessed on postoperative day 8
measure: Visual axis obstruction secondary to peripalpebral edema
timeFrame: It will be assessed on postoperative day 8.
measure: Ocular surface symptoms
timeFrame: This outcome will be assessed on postoperative days 8 and 30.
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Oftalmosanitas
Study officials:
affiliation: Unisanitas
name: Tatiana Gomez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00662727: Extracorporeal Shockwave Therapy for the Treatment of Refractory Angina Pectoris
Official title: Randomized, Placebo Controlled, Double Blind Clinical Trial Evaluating the Treatment of Patients With Refractory Angina Pectoris With Low Intensity Extracorporeal Shockwave Therapy Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Refractory Angina Pectoris
Keywords: Extracorporeal Shockwave Therapy
Myocardial Ischemia
Refractory Angina
Lead sponsor: Medispec
Sponsor class: INDUSTRY
Collaborators: name: Hadassah Medical Organization
First posted: 2008-04-21
Enrollment: 28
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: Low intensity shockwaves have been proven in animal studies to induce local growth of new blood vessels from existing ones.

The hypothesis of this study is that shockwave therapy could improve the symptoms of patients with refractory angina not amenable to revascularization with angioplasty or bypass surgery.

Detailed description: Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered to myocardial ischemic tissue. Shockwaves are created by a special generator and are focused using a shockwave applicator device. The treatment is guided by standard echocardiography equipment. The shockwaves are delivered in synchronization with Patient R-wave to avoid arrhythmias. The treatment is painless.

At first, the patient undergoes stress- SPECT testing to identify the ischemic areas. Following that, the same area is localized by the ultra-sound device and the shockwaves are focused to the ischemic area. Several treatments are required for optimal results.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with chronic stable angina pectoris.
* Documented myocardial segments with reversible ischemia
* AP CCS class of III-IV.
* Stable dosage of medication used to treat angina for at least 6 weeks prior to enrollment.
* Exercise tolerance time \< 10 min (modified Bruce)
* Two ETT tests results (within two weeks) averaging no more than 25% of their mean
* Documented epicardial coronary artery disease not amenable to angioplasty or CABG.
* Signed an IRB approved informed consent form.
* Life expectancy of \>12 months.

Exclusion Criteria:

* Intraventricular thrombus
* Malignancy in the area of treatment
* Severe COPD
* No smoking during the study procedure
* MI less \<3 months prior to treatment
* Severe Valvular disease
* Child bearing potential

Primary outcomes:
measure: Total Exercise Time
timeFrame: 6 months
Secondary outcomes:
measure: Change in SPECT
timeFrame: 6 months
measure: Change in AP-CCS
timeFrame: 6 months
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah-Hebrew University Medical Center
Study officials:
affiliation: Hadassah Medical Organization
name: David Leibowitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06449027: Safety, Efficacy and Pharmacokinetic Behavior of Leuprolide Injectable Emulsion for Premenopausal Breast Cancer Subjects.
Official title: A Phase III, Multicenter, Randomized, Open-Label Study to Assess the Safety, Efficacy and Pharmacokinetic Behavior of Leuprolide Injectable Emulsion for Premenopausal Breast Cancer Subjects.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Breast Cancer Subjects
Lead sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-06-07
Enrollment: 200
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 study is to assess the safety, efficacy and pharmacokinetic Behavior of Leuprolide Injectable Emulsion for Premenopausal Breast Cancer Subjects.

Detailed description: This is a multicenter, randomized, open-Label , non-inferiority phase III study . All premenopausal women breast cancer subjects were randomly allocated to either the study group or control group in a 1:1 ratio. Furthermore, all subjects received tamoxifen citrate treatment throughout the entire duration of the study. The efficacy of maintaining serum E2 levels ≤30 pg/mL at 4-48 weeks post-treatment will be assessed in both groups.

Eligibility criteria: Inclusion Criteria:

* Premenopausal female subjects aged 18 to 55 years old.
* Histological or cytological confirmation of HR+，HER2- premenopausal breast cancer.
* Subjects have any breast cancer surgery before informing, and no clinical residual local regional lesions were found after the surgery.
* Life expectancy is not less than 12 weeks.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate function of major organs.

Exclusion Criteria:

* History of evidence of distant metastatic lesions;
* Subjects have the history of new adjuvant or adjuvant endocrine treatment for breast cancer ( Excluding subjects receiving tamoxifen citrate tablets treatment for less than 12 weeks before informing).
* Active hepatitis B, hepatitis C or HIV in screening.

Primary outcomes:
measure: Observe the proportion of subjects whose E2 levels remain at postmenopausal levels between 4 and 48 weeks after treatment, to assess the Efficacy of Leuprolide Injectable Emulsion for Premenopausal Breast Cancer Subject.
timeFrame: 48 weeks
Secondary outcomes:
measure: Observe the concentration of LH, FSH, E2 after treatment.
timeFrame: 48 weeks
measure: Pharmacokinetic Parameter(AUC)
timeFrame: 48 weeks
measure: Pharmacokinetic Parameter(Cmax)
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Jian Zhang, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University
name: Zhimin Shao, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02147327: Effects of Cord Blood 25-hydroxy-vitamin D Level on Early Neonatal Morbidities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neonatal Hypocalcemia
Neonatal Sepsis
Keywords: vitamin D
cord blood
neonatal sepsis
neonatal morbidity
Lead sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
Sponsor class: OTHER
First posted: 2014-05-26
Enrollment: 120
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Newborns which are hospitalized in the Neonatal Intensive Care Unit of our hospital

Brief summary: Cholecalciferol (vitamin D3) is a prohormone and its active form is 1,25 dihydroxycholecalciferol. This hormone has effect on both calcium, phosphorus and bone metabolism and also bone morrow, muscle, heart and immune system. For a long time, maternal low vitamin D level is a well known problem for our country and the level was reported as \<10 ng/ml for 46-80% of mothers.The most prominent risk factor was determined as low socioeconomic status. Therefore, the level of 25-hydroxy-vitamin D is supposed to be in relation with several neonatal morbidities and maternal complications of pregnancy.


Eligibility criteria: Inclusion Criteria:

* Term or preterm newborns which are hospitalized in the Neonatal Intensive Care Unit of our hospital

Exclusion Criteria:

* Preterm babies born before the 24. gestational week
* Babies with complex cardiac anomalies and/or dysmorphic features

Primary outcomes:
measure: sepsis
timeFrame: 3 months but patients will be followed until discharge
measure: feeding intolerance
timeFrame: 3 months but patients will be followed until discharge
measure: hypocalcemia
timeFrame: 3 months but patients will be followed until discharge
measure: bronchopulmonary dysplasia
timeFrame: 3 months but patients will be followed until discharge
measure: patent ductus arteriosis
timeFrame: 3 months but patients will be followed until discharge
measure: retinopathy of prematurity
timeFrame: 3 months but patients will be followed until discharge
measure: maternal complications of pregnancy
timeFrame: from the beginning of gestation until birth process
Secondary outcomes:
measure: rachitism
timeFrame: 4 months but patients will be followed until discharge
Other outcomes:
Locations:
Study officials:
References: