louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03727256: Neuromuscular Electrical Stimulation and Ultrasound Therapies , Knee Osteoarthritis
Official title: Recep Tayyip Erdogan University Medical School
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: knee osteoarthritis
neuromuscular electrical stimulation
ultrasound therapy
Lead sponsor: Recep Tayyip Erdogan University Training and Research Hospital
Sponsor class: OTHER
First posted: 2018-11-01
Enrollment: 103
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the effects of ultrasound therapy and neuromuscular electrical stimulation on the muscle architecture and functional capacity of patients with knee osteoarthritis.

Detailed description: All participants who were satisfied with the inclusion criteria were randomly assigned to one of two study groups: Group 1- ultrasound therapy group; Group 2 - the neuromuscular electrical stimulation group. Group allocation was randomized in two blocks of 30 sealed envelopes without external marks, which were mixed and numbered from 1 to 30, containing a piece of paper with the group allocation. The researchers responsible for outcome measures and ultrasonograhic measurements were blinded to the patients' diagnosis or intervention.

Eligibility criteria: 1. Inclusion Criteria:

   Clinical diagnosis of knee osteoarthritis
2. Exclusion Criteria:

Cardiovascular diseases

Inflammatory diseases

Infectious diseases

Lower extremity weakness

Tumoral diseases

Knee surgery in the past six months

Intra-articular injection in the past six months

Primary outcomes:
measure: Visual analog scale
timeFrame: 3 weeks
measure: Western Ontario and McMaster Universities Arthritis Index
timeFrame: 3 weeks
measure: 15 meter walking test
timeFrame: 3 weeks
measure: Muscle measurements were made before and after treatment.
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rize
country: Turkey
facility: Gul Devrimsel
Study officials:
affiliation: Dr.
name: GUL DEVRIMSEL
role: STUDY_DIRECTOR
References:
Clinical trial NCT00650156: Pharmacokinetic and Safety Study With Adalimumab in Chinese Subjects With Mild Rheumatoid Arthritis
Official title: A Randomized, Parallel-group, Open-Label, Pharmacokinetic and Safety Study With Adalimumab in Chinese Subjects With Mild Rheumatoid Arthritis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2008-04-01
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pharmacokinetic and Safety Study with Adalimumab in Chinese Subjects with Mild Rheumatoid Arthritis


Eligibility criteria: Inclusion Criteria:

* Male or Female ages 18 years and older.
* Mild RA.
* Body weight less than 100 kg.

Exclusion Criteria:

* Wheelchair-bound or bedridden.
* Joint surgery involving joints to be assessed within this study, within two months prior to the Screening visit.
* Intra-articular, intramuscular or intravenous (IV) administration of corticosteroids within 28 days prior to the Screening visit.
* Prior treatment with any TNF antagonist, including adalimumab.
* Positive tuberculin PPD 5.
* Female subjects who are pregnant or breast-feeding.
* History of HIV or of being immuno-compromised.
* History of malignancy.
* Poorly controlled medical condition.

Primary outcomes:
measure: pharmacokinetic profile of a single subcutaneous dose of 40 and 80 mg adalimumab
timeFrame: Days 1, 2, 4, 6, 8, 11, 15, 22, & 29
Secondary outcomes:
measure: Adverse event profile
timeFrame: follow up to day 70 after dose
measure: VAS assessments
timeFrame: Days 1, 15 and 29
measure: Swollen and Tender Joint counts
timeFrame: Days 1, 15 and 29
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Site Reference ID/Investigator# 7181
Study officials:
affiliation: Abbott
name: Laura Redden, MD
role: STUDY_DIRECTOR
References:
citation: Burmester GR, Landewe R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.
Clinical trial NCT04313556: Clinical Outcome of Arthroscopic Lateral Release for Lateral Patellar Compression Syndrome
Official title: Clinical Outcome of Arthroscopic Lateral Release for Lateral Patellar Compression Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Pain Chronic
Keywords: Lateral patellar compression syndrome
Arthroscopic lateral release
Lysholm score
Lead sponsor: Hawler Medical University
Sponsor class: OTHER
First posted: 2020-03-18
Enrollment: 48
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: We performed a prospective case series study of 48 patients who suffered Lateral patellar compression syndrome who were diagnosed by clinical examination and confirmed by M.R.I. and failed conservative management and underwent isolated arthroscopic lateral patellar retinaculum release in Erbil Teaching Hospital, PAR Private Hospital and Hawler Private Hospital between December 2016 and August 2019.


Eligibility criteria: Inclusion Criteria:

* Lateral patellar compression syndrome proved by clinical,MRI and Arthroscopic examination

Exclusion Criteria:

1. Dislocated or history of dislocation.
2. Patellar instability.
3. Bony abnormality (trochlear groove hypoplasia or flat).
4. Osteoarthritis of the knee 3rd and 4th grades.
5. Infected knee.
6. Varus and valgus knee.
7. Rotational deformity of the lower extremity.
8. Miserable malalignment triad.
9. Anterior cruciate ligament, posterior cruciate ligament and medial collateral ligament rupture.
10. History of fracture around knee.
11. Focal Osteoarthritis of the lateral facet joint.
12. Chondral lesion (Outerbridge 3 and 4).

Primary outcomes:
measure: Lysholm Knee Score
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02386956: Hamstring Stretch Effect (STRETCH-HAMS)
Official title: Evaluation of Hamstrings Elongation After Different Physiotherapy Stretching Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postural; Defect
Keywords: manual therapy
muscle chains
Dynamic stretching
Active stretching
Lead sponsor: Universidad Miguel Hernandez de Elche
Sponsor class: OTHER
First posted: 2015-03-12
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized clinical trial to evaluate the elongation of the hamstrings after making different types of stretching. One group receives a stretch of global postural reeducation (RPG), another group receives a mobilization of sciatic nerve, and a third group received a placebo treatment. The evaluation of these treatments are done previously, immediately after and 20 min later. The test used to evaluate elongation are the Sit and Reach and active knee extension (AKE test).

Detailed description: Randomized clinical trial to evaluate the elongation of the hamstrings after making different types of stretching and mobilizations used in physiotherapy. This study is realized with university students to be long time studying in sitting position, and each subject is randomly assigned to one of three different groups. One group receives 10 minutes of global postural reeducation stretching (RPG), another group receives 10 minutes of bilateral mobilization of sciatic nerve, and a third group received a placebo treatment. The evaluation of these treatments are done previously, immediately after and 20 min later. The test used to evaluate elongation are the Sit and Reach and active knee extension (AKE test). The order of measurement of each test is also randomized in each subject. The intervention is always applied to the same physical therapist, and measurements were always performed by another physiotherapist blinded.

Eligibility criteria: Inclusion Criteria:

* college students spend four hours or more for day sitting

Exclusion Criteria:

* college students do not spend four hours or more for day sitting
* subjects with a traumatic problem, injuries or subjects in treatment of this injuries at the moment of the study

Primary outcomes:
measure: Sit and Reach test
timeFrame: 3 minutes
measure: AKE Test
timeFrame: 3 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Elche
country: Spain
facility: University Miguel Hernández
state: Alicante
Study officials:
affiliation: Universidad Miguel Hernandez de Elche
name: Carlos Lozano-Quijada, MPT
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Miguel Hernandez de Elche
name: Emilio J Poveda-Pagán, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01379456: Eva-Hip, Evaluation of Rehabilitation After Hip-fracture
Official title: The Effect on Gait and Activity Level of a Physiotherapy Intervention Aimed at Improving Mediolateral Stability 4 Months After a Hip Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fracture
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Trondheim Kommune
name: Norsk kvinners sanitetsforening
First posted: 2011-06-23
Enrollment: 223
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effect on gait and activity of a home based physiotherapy intervention 4-6 months after the fracture. The investigators hypothesis is that exercises performed after the initial rehabilitation, which focuses on specific components of gait control will improve gait and increase level of activity.


Eligibility criteria: Inclusion Criteria:

* Home dwelling prior to fracture
* age\>70yr
* able to walk 10m

Exclusion Criteria:

* expected life expectancies \<3 months
* exercises contraindicated due to medical conditions

Primary outcomes:
measure: change in gait speed
timeFrame: 4,6 and 12 months postfracture
Secondary outcomes:
measure: change in activity level
timeFrame: 4,6 and 12 month postfracture
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Norwegian University of Science and Technology
Study officials:
affiliation: Department of Neuroscience, Norwegian University of Science and Technology
name: Olav Sletvold, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thingstad P, Taraldsen K, Hagen G, Sand S, Saltvedt I, Sletvold O, Helbostad JL. Effectiveness of task specific gait and balance exercise 4 months after hip fracture: protocol of a randomized controlled trial--the Eva-hip study. Physiother Res Int. 2015 Jun;20(2):87-99. doi: 10.1002/pri.1599. Epub 2014 Jul 3.
citation: Hektoen LF, Saltvedt I, Sletvold O, Helbostad JL, Luras H, Halsteinli V. One-year health and care costs after hip fracture for home-dwelling elderly patients in Norway: Results from the Trondheim Hip Fracture Trial. Scand J Public Health. 2016 Dec;44(8):791-798. doi: 10.1177/1403494816674162. Epub 2016 Oct 23.
citation: Taraldsen K, Thingstad P, Dohl O, Follestad T, Helbostad JL, Lamb SE, Saltvedt I, Sletvold O, Halsteinli V. Short and long-term clinical effectiveness and cost-effectiveness of a late-phase community-based balance and gait exercise program following hip fracture. The EVA-Hip Randomised Controlled Trial. PLoS One. 2019 Nov 18;14(11):e0224971. doi: 10.1371/journal.pone.0224971. eCollection 2019.
Clinical trial NCT05815056: Comparaison Between Digital and Drug Induced Sedation in Veinous Access Device Implantation
Official title: Comparaison Between Virtual Reality Hypnosis and Drug Induced Sedation in Veinous Access Device Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oncology
Keywords: central veinous catheter
virtual reality induced hypnosis
Lead sponsor: Centre Hospitalier Regional de Huy
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1 arm with anaesthetic drugs vs hypnosis induced by virtual reality
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare in patients who need an implantation of a veinous access device the sedation with anesthesiologic drugs and with hypnosis using virtual reality material. The main question it aims to answer is:

• is hypnosis using virtual reality as safe and powerfull than usual anesthesiologic drugs.

Participants will complete a preoperative and postoperative questionnaire. They will be contacted by phone pre and postoperatively.

If there is a comparison group: Researchers will compare drug induced sedation and hypnosis induced by virtual reality to see if they are similar in efficacy and sides effects.

Detailed description: This study has two arms. All patients has the same preparation to surgery. They had lorazepam 2.5 mg 30 minutes before the surgery. In operative theater, they are randomly chosen between anesthetic protocol (sufentanyl 5mg intravenous) or digital sedation (Sedakit(R) ) with hypnosis induced by virtual reality.

Patients complete an anxiety test (hamilton scale) 2 days before the surgery and 2 days after the surgery. They are called by an external psychiatrist 1 day before the surgery and 3 days after to evaluate the anxiety link to the procedure.

Eligibility criteria: Inclusion Criteria:

* need for a venous device implantation

Exclusion Criteria:

* need for a general anaesthesia
* unability to give oral consent
* under 18 years

Primary outcomes:
measure: successful implantation of a veinous access device
timeFrame: immediately after surgery
Secondary outcomes:
measure: patient comfort
timeFrame: during the surgery
measure: implantation lenght
timeFrame: during the surgery
measure: feeling lenght
timeFrame: immediately after the surgery
measure: post operative anxiety using the hamilton anxiety scale
timeFrame: 2 days after the surgery
Other outcomes:
Locations:
city: Huy
country: Belgium
facility: CHR de Huy
Study officials:
affiliation: CHR de Huy
name: JeanFrancois Maillart, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03439956: Obstetric Outcomes After Transvaginal Specimen Extraction in Gynecological Laparoscopy
Official title: Evaluation of Obstetric Outcomes After Transvaginal Specimen Extraction in Gynecological Laparoscopy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy Complications
Delivery;Abnormal;Stillbirth
Keywords: Obstetric outcomes
Transvaginal specimen extraction
Gynecological laparoscopy
Lead sponsor: Università degli Studi dell'Insubria
Sponsor class: OTHER
First posted: 2018-02-20
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women that underwent previous laparoscopic myomectomy or ovarian cystectomy with transvaginal specimen extraction (cases) and pregnant women that did not.

Brief summary: One of the most important downsides of endoscopic surgery is the need to remove surgical specimens of different sizes through very small incisions. This step should ensure the complete retrieval of the surgical specimen with concomitant preservation of its integrity (if possible) in order to avoid intraabdominal contamination of potentially infected or malignant tissues. Possibilities for specimen extraction during laparoscopy include minilaparotomy, enlargement of an ancillary port, transumbilical extraction, and transvaginal extraction through posterior colpotomy.

Although recent evidence has already suggested that transvaginal extraction through posterior colpotomy is a safe and feasible option, to date there are no published data about obstetric outcomes after this procedure.

For this reason, the current study aims to evaluate obstetric outcomes between women that underwent transvaginal specimen extraction through posterior colpotomy and women who did not.


Eligibility criteria: Inclusion Criteria:

* Pregnancy

Exclusion Criteria:

* Any pre-existent cause of high risk for adverse obstetric outcomes.

Primary outcomes:
measure: Cesarean sections
timeFrame: During the whole study period (2 years).
Secondary outcomes:
measure: Operative deliveries
timeFrame: During the whole study period (2 years).
measure: Gestational age at deliveries
timeFrame: During the whole study period (2 years).
measure: Pregnancy complications
timeFrame: During the whole study period (2 years).
Other outcomes:
Locations:
Study officials:
affiliation: Università degli Studi dell'Insubria
name: Antonio Simone Laganà, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03269656: Age Gene/Environment Susceptibility Reykjavik Study
Official title: Association of Pre-diagnostic Vitamin D Levels and Survival in Older Individuals With Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasms
Keywords: Vitamin D
Cancer
Survival
Lead sponsor: Icelandic Heart Association
Sponsor class: OTHER
Collaborators: name: University of Iceland
First posted: 2017-09-01
Enrollment: 5764
Sex: ALL
Minimum age (years): 66
Maximum age (years): 98
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In 1967, all 30,795 men and women living in the capital area of Iceland and born between 1907 and 1935 were invited by the Icelandic Heart Association to join a prospective cohort study. Approximately 19,000 attended the clinic at least once and became participants of the Reykjavik Study. Subsequently, in 2002, a random sample of the cohort comprising 5,764 men and women who were still alive in Iceland and aged 66 to 96 years entered the Ages Gene/Environment Susceptibility (AGES) - Reykjavik Study

Brief summary: 5764 men and women in Iceland, aged 66 to 96 years entered the Ages Gene/Environment Susceptibility (AGES) - Reykjavik Study. Serum 25(OH)D was measured in 5,519 of all 5,764 (96%) participants at study entry in year 2002 through 2006. The main emphasis was on exploring whether pre-diagnostic serum levels of 25(OH)D were associated with survival after cancer diagnosis.


Eligibility criteria: Inclusion Criteria:

* To participate in the AGES-Reykjavik study

Exclusion Criteria:

* To be diagnosed with cancer before study entry

Primary outcomes:
measure: Overall survival
timeFrame: From date of diagnosis until death or censored at end of the follow-up (December 31, 2014)
measure: Cancer survival
timeFrame: From date of diagnosis until cancer death or censored at the end of the follow-up (December 31, 2014)
Secondary outcomes:
measure: Cancer diagnosis
timeFrame: From date of blood draw (study entry) until cancer diagnosis, death or end of the observation period (December 31, 2014) whichever occurred first
Other outcomes:
Locations:
Study officials:
affiliation: University of Iceland
name: Johanna Torfadottir, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Harris TB, Launer LJ, Eiriksdottir G, Kjartansson O, Jonsson PV, Sigurdsson G, Thorgeirsson G, Aspelund T, Garcia ME, Cotch MF, Hoffman HJ, Gudnason V. Age, Gene/Environment Susceptibility-Reykjavik Study: multidisciplinary applied phenomics. Am J Epidemiol. 2007 May 1;165(9):1076-87. doi: 10.1093/aje/kwk115. Epub 2007 Mar 10.
Clinical trial NCT00264056: Efficacy of Chemotherapy Combined With Regional Hypothermia in Advanced Malignant Melanoma Patients With Progressive Soft Tissue Metastases
Official title: Evaluation of the Safety and Efficacy of Systemic Chemotherapy Combined With Regional Hypothermia in Advanced Malignant Melanoma Patients With Locally Inoperable Progressive Soft Tissue Metastases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Advanced Metastastic Malignant Melanoma
Refractory to First-Line Chemotherapy Irresectable Progressive Soft Tissue Metastases
Keywords: malignant melanoma
hyperthermia
chemotherapy
Lead sponsor: Fachklinik Hornheide an der Universität Münster
Sponsor class: OTHER
First posted: 2005-12-12
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The incidence of malignant melanoma continues to rise throughout the world. Approximately 12 in 100,000 Germans are diagnosed with malignant melanoma per year. Malignant melanoma is often very aggressive since it may spread both through the lymphatic system and the bloodstream at an early stage of disease.

While treatment of localized disease is mostly surgical, in patients with extensive disease, prognosis remains poor; the primary standard therapy of metastastic disease comprises dacarbazine (DTIC) eventually combined with other chemotherapeutic agents e.g., cisplatin or BCNU. The duration of response to systemic chemotherapy is generally short and so far, no standard second-line treatment has been established.

To study the potential additional therapeutic effects of regional hyperthermia in advanced malignant melanoma patients with progressive chemotherapy refractory soft tissue metastases, in the present trial, we sought to compine local hyperthermia with concomitant systemic second-line chemotherapy.


Eligibility criteria: Inclusion Criteria:

* age between 18 and 70
* histologically proven malignant melanoma with advanced inoperable soft tissue metastases
* progressive disease upon systemic first-line chemotherapy
* 2 or more bidimensionally measurable soft tisue lesions
* WHO performance status (ECOG) of 2 or more
* life expectancy of 8 weeks and more
* prior informed consent

Exclusion Criteria:

* participation in other therapy studies
* pregnancy or breast feeding
* concomitant clinically significant infection
* cardiac pacemaker or other medical implants, or implants within the hyperthermia treated region (including a safe distance of 5 cm)
* lack of physiological heat sensitivity within the hyperthermia treated region (including a safe distance of 5 cm)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Münster
country: Germany
facility: Fachklinik Hornheide at the University of Münster, Germany
Study officials:
affiliation: Fachklinik Hornheide an der Universität Münster
name: Jens Atzpodien, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: