louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04381091: Expanded Access Program for Idebenone in Patients With Leber's Hereditary Optic Neuropathy Who Completed the LEROS Study
Official title: Expanded Access Program for Idebenone in Patients With Leber's Hereditary Optic Neuropathy Who Completed the LEROS Study
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Leber's Hereditary Optic Neuropathy
Lead sponsor: Santhera Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2020-05-08
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Expanded Access Program for Idebenone in Patients with Leber's Hereditary Optic Neuropathy who completed the LEROS Study

Detailed description: see above

Eligibility criteria: Inclusion Criteria:

* Patients who completed the LEROS study, who attended the end of study visit in LEROS and who in the opinion of investigator could benefit from continuation of idebenone treatment.
* Signed and dated Informed Consent Form (to be obtained at the Enrollment Visit from patient or parent/legal guardian (if applicable) prior to dispensing idebenone to the patient).

Exclusion Criteria:

* Patients who, in the opinion of the LEROS investigator, had unacceptable tolerability of idebenone treatment in LEROS trial.
* Patients who prematurely discontinued the LEROS study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01944891: Diet and Nutritional Status of Adolescent Girls in Zambézia, Mozambique
Official title: Estudo do Estado Nutricional e da Dieta em Raparigas Adolescentes na Zambézia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nutritional Status
Diet
Keywords: Adolescent girls
Mozambique
Diet
Anthropometrics
Serum biomarkers
Lead sponsor: University of Helsinki
Sponsor class: OTHER
First posted: 2013-09-18
Enrollment: 551
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adolescent girls living in Quelimane city, Maganja da Costa district and Morrumbala district.

Brief summary: Data on the diet and nutritional status of adolescent girls in Zambézia Province, Mozambique was collected. A cross-sectional study was carried out in 2010 in two seasons, January-February and May-June. Participants (total n=551) were recruited from Quelimane (the provincial capital), Maganja da Costa district and Morrumbala district.


Eligibility criteria: Inclusion Criteria:

Girls in the target age range who were able to visit the study centre and didn't have any significant illness preventing participation were considered eligible.

Exclusion Criteria:•

* age not between 15 and 18 years
* any apparent significant illness, disability or unstable medical condition which could lead to difficulty participating in the study
* unwillingness to participate in the study
* unwillingness or inability to arrive at the study location at the requested time.

Primary outcomes:
measure: Blood vitamin and mineral concentrations
timeFrame: cross-sectional 2010, single measurement
measure: Dietary assessment
timeFrame: cross-sectional 2010, single measurement
Secondary outcomes:
measure: Diseases (intestinal helminths, malaria parasitemia, HIV-status)
timeFrame: cross-sectional 2010, single measurement
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Department of Food and Environmental Science, University of Helsinki
Study officials:
affiliation: University of Helsinki
name: Marja L Mutanen, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Freese R, Korkalo L, Vessby B, Tengblad S, Vaara EM, Hauta-alus H, Selvester K, Mutanen M. Essential fatty acid intake and serum fatty acid composition among adolescent girls in central Mozambique. Br J Nutr. 2015 Apr 14;113(7):1086-95. doi: 10.1017/S0007114515000306. Epub 2015 Mar 16.
citation: Korkalo L, Freese R, Fidalgo L, Selvester K, Ismael C, Mutanen M. A Cross-Sectional Study on the Diet and Nutritional Status of Adolescent Girls in Zambezia Province, Mozambique (the ZANE Study): Design, Methods, and Population Characteristics. JMIR Res Protoc. 2014 Mar 5;3(1):e12. doi: 10.2196/resprot.3109.
Clinical trial NCT02579291: Dry Needling in Patients Who Had Experience Stroke
Official title: Changes in Spasticity, Motor Function and Stabilometry After Dry Needling of the Tibialis Posterior Muscle in Post-stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Dry needling
Spasticity
Motor function
Stabilometry
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2015-10-19
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Individuals who had experience a stroke usually suffer from spasticity at medium and long-terms. The presence of spasticity in the lower extremity implies several impairments for standing and walking inducing high disability. A recent study has proposed the use of dry needling for improving spasticity in the lower extremity. No study has investigated the effects of deep dry needling inserted into spastic musculature in stabilometry and moto function in patients who had experience a stroke. A randomized controlled trial investigating the effects of the inclusion of deep dry needling into a Bobath interventional program on spasticity, motor function and balance (stabilometry) in individuals who had experience a stroke


Eligibility criteria: Inclusion Criteria:

* First-ever unilateral stroke;
* hemiplegia resulting from stroke;
* unilateral equinovarus gait with independent walk;
* able to ambulate without supporting devices

Exclusion Criteria:

* recurrent stroke;
* previous treatment with nerve blocks, motor point injections with neurolytic agents for spasticity at any time, or with BTX-A in the previous 6 months
* not independent in the basic activities of daily living
* cognitive deficits;
* progressive or severe neurologic diseases;
* fear to needles;
* any contraindication for dry needling

Primary outcomes:
measure: Changes in spasticity before and 10 minutes after the intervention
timeFrame: Baseline and immediate after the intervention
Secondary outcomes:
measure: Changes in motor function before and 10 minutes after the intervention
timeFrame: Baseline and immediate after the intervention
measure: Changes in stabilometry outcomes before and 10 minutes after the intervention
timeFrame: Baseline and immediate after the intervention
Other outcomes:
Locations:
city: Alcorcon
country: Spain
facility: Cesar Fernandez-de-Las-Peñas
state: Madrid
Study officials:
affiliation: Universidad Rey Juan Carlos
name: CESAR FERNANDEZ-DE-LAS-PEÑAS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sanchez-Mila Z, Salom-Moreno J, Fernandez-de-Las-Penas C. Effects of dry needling on post-stroke spasticity, motor function and stability limits: a randomised clinical trial. Acupunct Med. 2018 Dec;36(6):358-366. doi: 10.1136/acupmed-2017-011568. Epub 2018 Jul 9.
Clinical trial NCT00959491: A Prospective Study of a New Immunological Fecal Occult Blood Test
Official title: A Prospective Study of a New Immunological Fecal Occult Blood Test in Patients Referred for Colonoscopy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colonoscopy
Occult Blood
Immunologic Tests
Keywords: Colonoscopy
Occult Blood
Fecal
Lead sponsor: National Institute of Gastroenterology, Cuba
Sponsor class: OTHER
First posted: 2009-08-14
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Residents of Havana City admitted at the investigation center.

Brief summary: The purpose of the investigators study is to evaluate the diagnostic ability of a new immunological fecal occult blood test in Cuban patients undergoing colonoscopy .

Detailed description: Colorectal cancer is a major cause of cancer deaths in many countries. Therefore, the importance of screening for the early detection of colorectal cancer is evident. Fecal occult blood screening is proving to be an effective tool for detecting premalignant adenomas and colon cancer since the guaiac-based test was introduced in the late 1960s. However, several immunochemical fecal occult blood tests (IFOBTs) have become commercially available and the majority of these have demonstrated equal or superior sensitivities and specificities than the guaiac-based tests. Therefore, IFOBTs are replacing guaiac based tests despite their higher costs.In this study we evaluate the diagnostic accuracy of a new IFOBT and compare with the findings on colonoscopy.

Eligibility criteria: Inclusion Criteria:

* Patients (men or women) that are \>18 years of age referred to colonoscopy.

Exclusion Criteria:

* Visible rectal bleeding
* Known diagnosis of inflammatory bowel disease
* Hematuria
* Menstruation at the time of obtaining a stool specimen
* Patients taking medication such as non steroids anti inflammatory drugs and anticoagulants

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Havana
country: Cuba
facility: National Institute of Gastroenterology
Study officials:
affiliation: National Institute of Gastroenterology , Havana, Cuba
name: Luis C Bertot, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04663191: Intraoperative Conversion During Video-assisted Thoracoscopy Resection for Lung Cancer Does Not Alter Survival
Official title: Intraoperative Conversion During Video-assisted Thoracoscopy Resection for Lung Cancer Does Not Alter Survival
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Video-assisted Thoracoscopic Surgery
Lung Cancer
Lobectomy
Survival
Surgery
Keywords: video-assisted thoracoscopic surgery
lung-cancer surgery
intraoperative conversion to open surgery
lobectomy
survival
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2020-12-10
Enrollment: 843
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients treated by anatomical lobar pulmonary resection (lobectomy, bilobectomy) or anatomical sublobar pulmonary resection (segmentectomy) for non-small cell lung cancer (NSCLC), either by VATS (eventually with intraoperative conversion) or upfront thoracotomy.

Brief summary: Anatomical resection with systematic lymph-node dissection is currently the standard of care for the treatment of early stage non-small cell lung cancer. The use of minimally invasive approaches has increased greatly over the last two decades \[either video-assisted thoracoscopic surgery (VATS) or robotic-assisted thoracoscopic surgery (RATS)\], as they provide the patient with better outcomes than open thoracotomy. Minimally invasive VATS lobectomy for a standard case is generally a straightforward procedure for a well-trained surgical team, although concomitant preoperative pathologies or intraoperative findings/adverse events may result in technical difficulties, leading to intraoperative conversion, commonly by thoracotomy.

The investigators aimed to assess long-term outcomes in a consecutive cohort of patients treated by anatomical pulmonary resection either using VATS, VATS requiring intraoperative conversion to thoracotomy, or upfront open thoracotomy for lung-cancer surgery.


Eligibility criteria: Inclusion Criteria:

* All consecutive patients treated by anatomical lobar pulmonary resection (lobectomy, bilobectomy) or anatomical sublobar pulmonary resection (segmentectomy) for non-small cell lung cancer (NSCLC), either by VATS (eventually with intraoperative conversion) or upfront thoracotomy.

Exclusion Criteria:

* patients with non-anatomical pulmonary resection (wedge resection)
* patients with a histology other than NSCLC (benign or metastatic from another primitive cancer), stage IV NSCLC disease,
* patients with multiple primary NSCLC (synchronous or metachronous)
* patients with incomplete resection (R+)
* patient for whom a VATS approach was never considered

Primary outcomes:
measure: Overall survival during the follow-up period after surgery
timeFrame: from day of surgery up to 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT03201991: ALS Study Determining Various Biomarkers and Strength Comparison After Exercise
Official title: ALS Study Determining Various Biomarkers and Strength Comparison After Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Keywords: ALS
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2017-06-28
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the muscle strength of a muscle in the thigh after 12 weeks of home exercise.

Detailed description: Study participation lasts a total of three months and includes two study visits. Subjects are asked to undergo strength testing, physical exams, lab draws, and muscle biopsies at each study visit. Muscle biopsies are done in the quadriceps muscle. In between study visits, subjects are asked to maintain a weekly exercise regimen given to them by the study physical therapist.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of possible, probable or definite amyotrophic lateral sclerosis (ALS) based on the revised El-Escorial criteria
* Presence in ipsilateral leg of either weakness in any muscle group or of active denervation by needle electromyography (EMG) which is a surrogate marker of early denervation
* Ipsilateral quadriceps femoris strength: \>=4
* Ambulatory with or without assistance
* Revised ALS Functional Rating Scale (ALSFRS-R) Score \> 30
* Forced expiratory vital capacity (FVC) \>50% of predicted

Exclusion Criteria:

* ALSFRS-R ≤ 30
* Quadriceps femoris strength \<4
* Unable to walk or uses wheelchair as primary means of mobility
* More than mild atrophy of quadriceps
* Bleeding disorder or uptake of anticoagulants
* Unwilling to comply with exercise and needle muscle biopsy
* Not a good research candidate according to the medical opinion of investigator

Primary outcomes:
measure: Change in functional muscle strength
timeFrame: Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Omar Jawdat, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00822991: Sonazoid Enhanced Liver Cancer Trial for Early Detection
Official title: Sonazoid Enhanced Liver Cancer Trial for Early Detection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatocellular Carcinoma
Liver Cirrhosis
Hepatitis B
Hepatitis C
Keywords: Sonazoid
Early detection
Hepatocellular carcinoma
Liver cirrhosis
Lead sponsor: Kindai University
Sponsor class: OTHER
First posted: 2009-01-15
Enrollment: 760
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to prove usefulness of contrast-enhanced ultrasound (CE-US) using Sonazoid (TM) in the early detection of HCC as compared with conventional B-mode ultrasound (B-mode US) for hepatitis virus related cirrhosis, who are defined as super high-risk patients for hepatocarcinogenesis,Furthermore, to analyze whether early detection of HCC by CE-US has a survival benefit than that by B-mode US.


Eligibility criteria: Inclusion Criteria:

1. Age over 20
2. HBV or HCV related liver cirrhosis
3. No history of HCC
4. Diagnosed as liver cirrhosis histologically or clinically Histologically confirmed by liver biopsy Confirmed by formula of diagnosing cirrhosis Radiological finding Finding of portal hypertension Platelet\<130,000
5. Inpatient or outpatient
6. Patients who signed a written informed consent form

Exclusion Criteria:

1. History of hypersensitivity to egg yolk
2. Pregnant or lactating women and women who may be pregnant
3. Severe liver dysfunction(AST, ALT,or BIL level \>10ULN
4. Associated with HCC
5. Patients receiving interferon
6. Age under 20
7. Judged by investigator not to be appropriate for inclusion in this study

Primary outcomes:
measure: Size of HCC which is detected first
timeFrame: 10 years
Secondary outcomes:
measure: Time to detection of HCC
timeFrame: 10 years
measure: The improvement of prognosis of patients who are diagnosed in this study
timeFrame: 10 years
Other outcomes:
Locations:
city: Osaka-Sayama
country: Japan
facility: Kinki University School of Medicine, Department of Gastroenterology and Hepatology
state: Osaka
Study officials:
affiliation: Kindai University
name: Masatoshi Kudo, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kudo M, Hatanaka K, Kumada T, Toyoda H, Tada T. Double-contrast ultrasound: a novel surveillance tool for hepatocellular carcinoma. Am J Gastroenterol. 2011 Feb;106(2):368-70. doi: 10.1038/ajg.2010.432. No abstract available.
Clinical trial NCT02029391: Kinesio Taping in Subjects With Myofascial Pain Syndrome: a Randomized Controlled Trial
Official title: Kinesio Taping on Short Term Changes in Subjects With Myofascial Pain Syndrome: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myofascial Pain Syndrome
Keywords: Myofascial pain syndrome
taping
manual therapies
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2014-01-07
Enrollment: 31
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Musculoskeletal dysfunction is considered as a major public health problem affecting about one third of the adult population. Myofascial pain syndrome (MPS) characterized by myofacial trigger points as well as fascia tenderness are thought to be the main cause of musculoskeletal dysfunction. The aim of the treatment for musculoskeletal dysfunction is to reduce pain and restore normal function. Clinically, some evidence supports the application of kinesio tape in these patients. The underlying mechanism, however, is not clear. The investigators goal was to validate proposed mechanism of kinesio tape in these patients. The primary outcome are muscle stiffness, pain intensity and sensitivity.


Eligibility criteria: Inclusion Criteria:

* age between 20 and 60 years
* shoulder or neck pain corresponding with the area covered by the upper trapezius muscle
* Trigger point (taut band) in the upper trapezius muscle

Exclusion Criteria:

* diagnosis of fibromyalgia syndrome
* having undergone myofascial therapy within the past month before the study
* history of cervical spine or shoulder surgery
* previous history of a whiplash injury;
* diagnosis of cervical radiculopathy or myelopathy;
* taking medicine that might change the pain intensity or pain threshold, such as analgesics, sedatives, substance abuse (including alcohol, narcotics);
* a cognitive impairment that would prevent them from being able to understand and/or participate fully in the intervention or the measures.

Primary outcomes:
measure: Muscle stiffness
timeFrame: baseline, immediate after intervention and at week 1
Secondary outcomes:
measure: Visual analog scale (VAS)
timeFrame: baseline, immediate after intervention and at week 1
measure: Pressure pain threshold
timeFrame: baseline, immediate after intervention and at week 1
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Institute of Physical Therapy, National Taiwan University
Study officials:
affiliation: Institute of Physical Therapy, National Taiwan University
name: Jiu-Jeng Lin, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01885091: Efficacy and Safety Study of Kinerase® for Treatment of Cutaneous Facial Photodamage
Official title: Kinerase® Interactive Skin-care Study: A Multicentre, Phase IV, Single-arm, Open-label Trial to Evaluate the Efficacy and Safety of Kinetin, N6-furfuryladenine, 0.1% for Treatment of Cutaneous Facial Photodamage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Skin Roughness
Mottling
Blotchiness
Pigmentation
Fine Wrinkles
Lead sponsor: Menarini (Thailand) Limited
Sponsor class: INDUSTRY
First posted: 2013-06-24
Enrollment: 100
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the K.I.S.S. study is to evaluate the efficacy of Kinerase® Cream (Kinetin 0.1%) in Thai patients, on the basis of the severity and clinical signs of facial photodamage.


Eligibility criteria: Inclusion Criteria:

1. Male and female subjects older than 35 years of age and less than 65 years of age.
2. Subjects with mild, moderate or severe facial photodamage as assessed by a 10-point scale.
3. Subjects willing to sign an informed consent and adhere to all protocol requirements.

Exclusion Criteria:

1. Male and female subjects with suspected porphyria, systemic or cutaneous erythematosus lupus, or any other photosensitizing disorder or drug-induced photosensitization.
2. Subjects with chronic or recurring skin disease or disorder.
3. Subjects with any active infectious skin disorder (Herpes simplex, molluscum contagiosum, and facial warts).
4. Subjects with skin cancer of the facial tissues.
5. Subjects who have received any laser/ intense pulsed light (IPL) / chemical peel in the 2 months preceding the screening visit.
6. Subjects with a history of topical and/or oral isotretinoin use, 6 months prior to the screening visit.
7. Subjects who have been on topical Retin-A or Renova in the 2 months prior to the screening visit.
8. Subjects who have used topical alpha-hydroxy acid skin care products in the month preceding the screening visit.
9. Subjects currently on any anti-aging products and who wish to continue use of their products.
10. Subjects requiring concurrent treatment that would interfere with the study assessments.
11. Pregnant or lactating female subjects.

Primary outcomes:
measure: To assess the physician's evaluation and patient's self-evaluation at 12 weeks.
timeFrame: 12 weeks
measure: To assess the physician's evaluation and patient's self-evaluation at 4 weeks.
timeFrame: 4 weeks
measure: To assess the physician's evaluation and patient's self-evaluation at 8 weeks.
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: I-Sky Center Chidlom branch
Study officials:
affiliation: iSKY Innovative Skin & Laser Surgery Center
name: Rungsima Wanitphakdeedecha, MD, MA, MSc
role: PRINCIPAL_INVESTIGATOR
References: