louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02095990: Efficacy and Safety of a 4% Hydroquinone Cream for the Treatment of Melasma
Official title: Efficacy and Safety of a 4% Hydroquinone Cream (Melanoderm 4%) for the Treatment of Melasma: a Randomized Controlled Split-face Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Facial Melasma
Keywords: Facial Melasma
Lead sponsor: Mesoestetic Pharma Group S.L.
Sponsor class: INDUSTRY
First posted: 2014-03-26
Enrollment: 17
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the ability of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) to reduce melasma on the face, using a split-face randomization design, evaluating the MASI Score from baseline to week 4 and week 8, in both half-faces receiving active treatment vs. placebo.

To assess the tolerance of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) on the face.

To assess patients' satisfaction regarding Melanoderm 4% Crema after 8 weeks.


Eligibility criteria: Inclusion Criteria:

* Adult women aged between 18-65 years old.
* Fitzpatrick phototypes I to IV.
* Presenting moderate to severe facial melasma facial, with a basal Melasma Area and Severity Index (MASI Index) between 10 and 20.
* Women of childbearing potential must use an adequate contraceptive method to avoid pregnancy and must have a negative pregnancy test in a maximum of 72 hours before receiving the trial treatment.
* Breastfeeding women will not be included in the study.
* Having given freely and expressly her informed consent.

Exclusion Criteria:

* Those with any history of allergy or hypersensitivity to a cosmetic product, hydroquinone, or one of the ingredients of the investigational products.
* Fitzpatrick phototype V.
* Skin pigmentation diseases different to melasma.
* Evidence of active cancer disease or diagnosis of cancer in the last year.
* Those receiving any topical or oral treatment that could interfere with melasma.
* Pregnant or breastfeeding women, or those expecting to get pregnant during the study.
* Evidence or suspicion of low compliance with the study visits and procedures.
* Participation in other clinical trial simultaneously or in the previous 3 months.

Primary outcomes:
measure: To assess the ability of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) to reduce melasma on the face.
timeFrame: Baseline, week 4, week 8.
Secondary outcomes:
measure: To assess the tolerance of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) on the face.
timeFrame: Week 4, Week 8, Follow-up period (Week 12)
Other outcomes:
measure: To assess patients' satisfaction regarding Melanoderm 4% Crema.
timeFrame: Week 8
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Susana Puig, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02202590: Using Spectrally Encoded Confocal Microscopy (SECM) to Image the Esophagus
Official title: Pilot Study to Image the Esophagus Using Spectrally Encoded Confocal Microscopy (SECM)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Eosinophilic Esophagitis
Keywords: SECM
Esophagus
Eosinophilic Esophagitis
Allergy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2014-07-29
Enrollment: 84
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal of this study is to test the feasibility and the tolerability of a tethered spectrally encoded confocal microscopy (SECM) capsule and to use it to image the esophagus.

Detailed description: 72 subjects including healthy volunteers, patients with a suspicion of having Eosinophilic Esophagitis (EoE) and patients with a clinical diagnosis of EoE will be recruited and asked to swallow the SECM capsule while being awake and unsedated. The capsule is attached to a tether which allows the operator to control as well as navigate the capsule as it progresses down the esophagus using natural propulsive force called peristalsis.

As the capsule progresses, multiple 2-dimensional cross sectional images of the esophagus are acquired. Images are analyzed at a later stage.

Eligibility criteria: Inclusion Criteria:

* Subject must be a healthy volunteer
* OR subject must have a suspicion of EoE
* OR subject must have a prior clinical suspicion of EoE
* Subject must be older than 14 years of age
* Subject must be able to give informed consent

Exclusion Criteria:

* Subjects with the inability to swallow pills and capsules.
* Esophageal fistula and/or esophageal strictures with a stricture diameter that is smaller than the diameter of the capsule.

Primary outcomes:
measure: SECM Imaging quality. Assessed qualitative values like resolution, tissue architecture, background scatter etc.
timeFrame: A single 20 minute visit (5-7 minute imaging).
measure: Tolerability of SECM Capsule Imaging Procedure in Healthy and EoE Participant, measured by feedback scores.
timeFrame: Questionnaire adminstered directly after the imaging portion has been completed.
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Guillermo Tearney, MD., PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04981990: Single Lung Ventilation Versus Two Lung Ventilation
Official title: Single Lung Ventilation Versus Two Lung Ventilation in Video Assisted Lung Surgeries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypoxemia
Single Lung Ventilation
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-07-29
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two equal groups: the first group undergoing lung surgeries with single lung ventilation by double lumen endotracheal tube, the second group undergoing lung surgeries with two lung ventilation using conventional single lumen endotracheal tube
Primary purpose: OTHER

Brief summary: Hypoxia in single lung ventilation versus two lung ventilation in video assisted lung surgeries

Detailed description: Incidence of hypoxia in single lung ventilation by double lumen endotracheal tube "of choice in lung surgeries" versus incidence of hypoxia in two lung ventilation by conventional single lumen endotracheal tube "intermittent two lung ventilation"

Eligibility criteria: Inclusion Criteria:

* Age group: Adult patients from age of 21 years to 60 years
* Sex: Both sexes
* ASA Classification: patients with ASA classification II, III.
* Elective lung surgeries using video assisted thoracoscopic surgeries.

Exclusion Criteria:

* Patients refuse to give informed consent.
* ASA Classification: ASA IV.
* Failure of thoracoscopic surgeries and continue as open thoracotomy
* Patients with ischemic heart diseases, where hypoxemia might be preexisting, or patient be more vulnerable to hypoxemia whatever the technique or time of hypoxia.
* Emergency lung surgeries.
* Patients underwent previous lung surgeries of any cause.
* Patients with pathology to the non-operated side.

Primary outcomes:
measure: Incidence of hypoxemia
timeFrame: Intraoperative to first 24 hours post operative
Secondary outcomes:
measure: Incidence of failure to correct Hypoxemia in single lung ventilation
timeFrame: Intraoperative
measure: Incidence of failure of two lung ventilation to create optimum surgical field
timeFrame: Intraoperative
measure: Incidence of post operative complications
timeFrame: First 24 hours post operative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Aun Shams University Hospitals
Study officials:
affiliation: Anesthesiology department
name: Esraa Abdellatif, M.B., B.Ch.
role: PRINCIPAL_INVESTIGATOR
affiliation: Anesthesiology department
name: Omar El safty, MD
role: STUDY_CHAIR
affiliation: Anesthesiology department
name: Salwa Omar, MD
role: STUDY_DIRECTOR
affiliation: Anesthesiology department
name: Mohamed Taeimah, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06023290: Validation of Digital Heart Rhythm Devices in the Detection of Atrial Fibrillation
Official title: Validation of Digital Heart Rhythm Devices in the Detection of Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Ziekenhuis Oost-Limburg
Sponsor class: OTHER
First posted: 2023-09-05
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The VALIDATION study aims to evaluate the performance of four state-of-the-art digital heart rhythm devices (Preventicus®, FibriCheck®, Apple Watch®, 6L Kardia Mobile®) for the detection of atrial fibrillation.


Eligibility criteria: Inclusion Criteria:

* The patient is an ambulatory cardiology patient.
* The patient is at least 18 years old.
* The patient is sinus or in atrial fibrillation.
* The patient is able to perform the study procedures together with the study assistant.

Exclusion Criteria:

* Patients with a pacemaker
* Inclusion in another clinical trial that may influence the results of this trial
* The patient is unable to comprehend the informed consent.

Primary outcomes:
measure: Sensitivity
timeFrame: During the heart rhythm measurements
measure: Specificity
timeFrame: During the heart rhythm measurements
measure: Accuracy
timeFrame: During the heart rhythm measurements
measure: Cramer's V
timeFrame: During the heart rhythm measurements
Secondary outcomes:
measure: Positive predictive value
timeFrame: During the heart rhythm measurements
measure: Negative predictive value
timeFrame: During the heart rhythm measurements
measure: Patient preference score (for the use of the diagnostic devices)
timeFrame: During the heart rhythm measurements
Other outcomes:
measure: Sensitivity, specificity and Cramer's V using only measurements of sufficient quality for analysis
timeFrame: During the heart rhythm measurements
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
state: Limburg
Study officials:
References:
Clinical trial NCT03171090: Efficacy of Bilateral Ultrasonic Guided Sphenopalatine Ganglion Block in Maxilofacial Cancer Surgeries
Official title: Efficacy of Bilaterally Ultrasonic Guided Sphenopalatine Ganglion Block for Perioperative Pain Management in Maxilofacial Cancer Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maxillofacial Tumors
Lead sponsor: Assiut University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2017-05-31
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients will be randomly allocated according to computer - generated tables to one of two groups, group (A) ultrasonic guided sphenopalatine block using local anasthetic, group (B) ultrasonic guided sphenopalatine block using saline. Before induction anesthesia the following will be assessed, time needed to perform the technique, time till onset of the block, distribution of the block (Opthalmic, Maxillary, Mandibular) by needle brick.Intra and post- operatively the following will be assesse the quality of operative filed every 30 min intra-operatively using a pre- defined average category scale (ACS) (from 0 to 5), End tidal Sevo Flurane concentration will be recorded intra- operatively every 5 minutes, The total amount of Nitroglycerine used to achieve the target MAP and frequency of propranolol usage will be recorded,emergence time, postoperative VAS score and amount of meperdine used for rescue analgesia.


Eligibility criteria: Inclusion Criteria:

* Adults patients of ASA physical status I and II, aged 20-70 year who will be scaduled for Maxillo - facial cancer surgeries

Exclusion Criteria:

* patients with disfigurement and disturbed anatomy that will not allow easy access to the sphenopalatine ganglion, bleeding disorders, history of hepatic, renal or cardiopulmonary dysfunction, patients receiving drugs affecting coagulation or cardiovascular active medication are excluded also patients having infection or allergies to local anesthetics

Primary outcomes:
measure: Post - operative analgesia
timeFrame: 24 hours postopeatively
Secondary outcomes:
measure: total dose of analgesic consumption
timeFrame: 24 hours
measure: number of patients required analgesia
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: NCI, Cairo university
Study officials:
References:
Clinical trial NCT02917590: Dual-task Obstacle Crossing Training in Ambulatory Subjects With Spinal Cord Injury
Official title: Dual Task Obstacle Crossing: Effects on Walking and Balance Ability, and Relationship With Falls in Independent Ambulatory Patients With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Injuries, Spinal Cord
Keywords: Spinal cord injury
dual-task obstacle crossing
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2016-09-28
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Is dual-task obstacle crossing training more efficiently than single-task obstacle crossing training on the improvement of walking ability, balance ability, and lower extremity muscle strength in ambulatory subjects with spinal cord injury

Detailed description: To compare immediate effects of dual-task and single-task obstacle crossing training in ambulatory subjects with spinal cord injury

Eligibility criteria: Inclusion Criteria:

* independent ambulatory subjects with
* traumatic causes or non-progressive diseases
* sub-acute and chronic stage of injury (at least 3 month after injury)
* body mass index (BMI) between 18.5-29.9 kg/m2
* walk independently for at least 17 meters with or without assistive devices (Functional Independence Measure Locomotor (FIM-L) scores 5-7)
* able to read Thai

Exclusion Criteria:

* pain in the musculoskeletal system with a pain scale more than 5 out of 10 on a the visual analog scale (VAS)
* deformity in the joints that affect ambulatory ability
* unable to understand the commands and tests used in the study

Primary outcomes:
measure: 10MWT (Single-task)
timeFrame: 1 day
Secondary outcomes:
measure: 10MWT (Dual-task)
timeFrame: 1 day
measure: TUGT
timeFrame: 1 day
measure: FTSST
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Thailand
name: Sugalya Amatachaya, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03481790: Lactoferrin Versus Ferrous Sulphate for Treatment of Iron Deficiency Anaemia During Pregnancy
Official title: The Effect of Orally Administered Iron-saturated Lactoferrin on Systemic Iron Homeostasis in Pregnant Women Suffering From Iron Deficiency and Iron Deficiency Anaemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Iron Deficiency Anemia of Pregnancy
Keywords: iron deficiency anemia of pregnancy - lactoferrin
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2018-03-29
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the efficacy and tolerability of lactoferrin in contrast to ferrous sulphate in the context of iron deficiency anemia with pregnancy.

Half of participants will receive lactoferrin, while the other half will receive ferrous sulphate.

Detailed description: Lactoferrin and Ferrous sulfate are used to treat iron deficiency anemia in pregnancy.

Ferrous sulphate is the most commonly used treatment for iron deficiency anemia.

Lactoferrin is a new generation oral iron that has long been recognized as a member of the transferrin family of proteins and an important regulator of the levels of free iron in the body fluids and has the ability to enhance iron binding. Preliminary evidence suggests that lactoferrin may represent a promising new strategy for oral iron replacement.

Eligibility criteria: Inclusion Criteria:

* Pregnant women with single fetus
* Hb count \< 11g/dL
* ferritin level \< 12 ng/dL
* Gestational age (14 - 30 weeks)

Exclusion Criteria:

* Associated chronic medical disorder (CKD, liver disease, peptic ulcer and chronic blood loss).
* Associated bleeding disorder
* Anaemia requiring blood tranfusion (Hb \< 7g/dL)
* Hypersensitivity to iron preparations
* Haemoglobinopathies (G6PD, thalassemias, sickle cell disease)

Primary outcomes:
measure: Hemoglobin (Hb) level.
timeFrame: 4 weeks
Secondary outcomes:
measure: serum ferritin level.
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams Maternity Hospital
Study officials:
affiliation: Ain Shams Maternity Hospital
name: Ahmed Mamdouh
role: STUDY_DIRECTOR
References:
Clinical trial NCT05053490: Static Versus Dynamic Stretching; Short Term Effects On Physical Performance In Non-Athletes
Official title: Static Versus Dynamic Stretching; Short Term Effects On Physical Performance In Non-Athletes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Physical Fitness
Keywords: Static and dynamic stretching
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-09-22
Enrollment: 54
Sex: MALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants of group A will perform static stretches and group B will perform dynamic stretching. After a gap of 3 days, interventions will be switched, now group A will perform dynamic stretching and group B will perform static stretching.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will compare the short-term effects of static and dynamic stretching on the physical performance of undergraduate students who are not involved in athletic activities. It will be observed if a significant difference lies between these stretchings.

Detailed description: The individual participant will be assessed at baseline and then stretching will be performed after that. Group A will perform static stretching and group B will perform dynamic stretching. Immediate assessment will be done after 5 minutes, a second assessment will be done after 6 hours and a third one will be done after 24 hours to measure the short-term effects.

After that, a gap of 3 days will be given and stretching will be performed again. Now, group A will perform dynamic stretching and group B will perform static stretching. A similar assessment will be repeated after 5 minutes then 6 hours and then after 24 hours to determine the difference.

Eligibility criteria: Inclusion Criteria:

* Male undergraduate students aged between 18-25
* Lower Limb range; Hip SLR\>80 degree Knee flexion \>130 degree Ankle dorsiflexion \>20 degree
* Those who fall under normal BMI range

Exclusion Criteria:

* acute injuries of the lower limb.
* active participants of sports and any training programs.
* lower limb disabilities.

Primary outcomes:
measure: Endurance in meters.
timeFrame: 5 minutes
measure: Vertical jump in inches.
timeFrame: 5 minutes
measure: Agility in seconds.
timeFrame: 5 minutes.
measure: Flexibility in inches.
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Riphah international University
state: ICT
Study officials:
affiliation: Riphah International University
name: Waqar Ahmed Awan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00650390: Open Label Study to Assess Efficacy and Safety of the Fully Human Anti-TNF-Alpha Monoclonal Antibody Adalimumab
Official title: Open Label Study to Assess Efficacy and Safety of the Fully Human Anti-TNF-Alpha Monoclonal Antibody Adalimumab
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Rheumatoid Arthritis
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2008-04-01
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The study was to explore the efficacy of adalimumab in subjects previously treated with infliximab and failed infliximab treatment due to lack of efficacy or intolerance. To explore the safety of adalimumab in subjects previously treated with infliximab.


Eligibility criteria: Inclusion Criteria:

* Males and females \>= 18 years of age
* ACR criteria for RA diagnosis for at least 6 months
* Active RA defined as a DAS 28 \>3.2 at study entry
* Unsatisfactory response, loss of response or intolerance to prior infliximab treatment
* A negative pregnancy test for females of childbearing potential

Exclusion Criteria:

* Patient who had previous treatment with cyclophosphamide and chlorambucil
* Treatment within the last 8 weeks with infliximab
* Prior treatment with more than one DMARD or DMARD combination following infliximab treatment
* Prior treatment with biologics (Investigational or Commercial) RA therapies other than infliximab
* History of cancer, other than successfully treated squamous cell or basal cell carcinoma or lymphoproliferative disease
* Prior treatment with total lymphoid irradiation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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.