louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01508780: Combined Use of Angiography, Optical Coherence Tomography and Intravascular Ultrasound in Evaluation of Pulmonary Vascular Structure and Function in Patients With Pulmonary Arterial Hypertension Treated With Oral Bosentan
Official title: Combined Use of Angiography, Optical Coherence Tomography and Intravascular Ultrasound in Evaluation of Pulmonary Vascular Structure and Function in Patients With Pulmonary Arterial Hypertension Treated With Oral Bosentan
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Pulmonary Arterial Hypertension
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Actelion
First posted: 2012-01-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: It has been hypothesized that one of the benefits of bosentan relates to pulmonary vascular remodeling. The investigators believe that this study will help document the nature of beneficial changes that occur in patients with Pulmonary Arterial Hypertension (PAH) in response to bosentan therapy. In turn, demonstrating that changes in pulmonary vascular structure and function accompany clinical improvement.

Detailed description: Subjects will have Optical coherence tomography (OCT) and Intravascular Ultrasound (IVUS) imaging during the right heart catheterization that diagnoses them as having PAH. Subjects will start their bosentan and will be followed by monthly clinic visits for 4 months. At 4 months they will have repeat OCT and IVUS imaging.

Eligibility criteria: Inclusion Criteria:

1. WHO GROUP 1
2. AGE 18-75
3. Baseline 6-min walk distance (6MWD) between 200 and 450 m
4. Diagnosed with pulmonary artery hypertension during right heart catheterization (Mean Pulmonary Artery Pressure \> 25mmHg)

General Exclusion Criteria

1. Pregnant or nursing
2. Acute or chronic illness other than those associated with PAH (collagen vascular disease, human immunodeficiency virus, or anorexigen use)
3. Previously received any investigational medications, prostanoids, or phosphodiesterase inhibitors
4. eGFR \< 60
5. Angina
6. Syncope
7. Failing right ventricle
8. Hemoptysis

Primary outcomes:
measure: Change in the measurement of Pulmonary arterial intimal + Medial thickening by OCT pre and post treatment with bosentan at 4 months
timeFrame: Baseline and 4 months
Secondary outcomes:
measure: Change in pulmonary arterial pulsatility by IVUS pre and post treatment with bosentan at 4 months
timeFrame: Baseline and 4 months
measure: Change in pulmonary arterial pressure/elastic strain index by IVUS pre and post treatment with bosentan at 4 months
timeFrame: Baseline and 4 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Ik-Kyung Jang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01840280: A Non Interventional Study With Irinotecan Onkovis (Irinotecan) Utilized for the Treatment of Cancer
Official title: Open, Multicenter Observational Study of Irinotecan Utilized in Mono- or Combination Therapy for the Treatment of Advanced Colorectal Carcinoma.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma
Keywords: carcinoma
colorectal cancer
ambulant chemotherapy
treatment cycles
Irinotecan
Irinotecan onkovis
Quantity of Irinotecan
Packaging Sizes
Lead sponsor: Onkovis GmbH
Sponsor class: INDUSTRY
Collaborators: name: AKP Freiburg GmbH
First posted: 2013-04-25
Enrollment: 324
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated in practices, clinics, hospitals

Brief summary: The main purpose of this observational study with Irinotecan onkovis is to determine the number of treatment cycles and the quantity of Irinotecan onkovis needed for this purpose under the special circumstances of ambulant chemotherapy.

Onkovis aims to contribute to an economical utilization of the chemotherapeutics. This includes provision of appropriate packaging sizes to decrease the excess quantity to be discarded, and thus also follows this objective.

Secondary objective is the assessment of the side effects of Irinotecan onkovis. To this end, data regarding co-medication and adverse events are also collected.


Eligibility criteria: Inclusion Criteria:

* Indication for Irinotecan according to the SmPC and treating physician

Exclusion Criteria:

* according to the Irinotecan SmPC

Primary outcomes:
measure: The Quantity of Irinotecan onkovis needed per treatment cycle
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Adverse events during and after treatment
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Elstra
country: Germany
facility: Practice
city: Leipzig
country: Germany
facility: Practice
city: Naunhof
country: Germany
facility: Practice
city: Neustadt/Sachsen
country: Germany
facility: Practice
city: Werdau
country: Germany
facility: Practice
Study officials:
References:
Clinical trial NCT05449080: Disorders of Sex Development (DSD) 46.XY in Three Siblings
Official title: Disorders of Sex Development (DSD) 46.XY Due to Type 2 5-Α Reductase Deficiency in Three Siblings: Case Report From a Low-Resource Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Genotype
Keywords: Disorders of Sex Development
Type 2 5-alpha reductase deficiency
Lead sponsor: Universitas Padjadjaran
Sponsor class: OTHER
First posted: 2022-07-08
Enrollment: 3
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients were 3 female siblings with identical complaints of no menarche of varying ages. Patients were subjected to physical examination, lab tests and karyotype to determine their genotypes.

Brief summary: This is a case series of three siblings with DSD 46,XY with relevant discussion

Detailed description: This is a case series of three sisters with DSD 46 X,Y. Three sisters, aged nineteen, seventeen, and fifteen years old came with an identical complaint of late menarche. Physical examinations, lab results and karyotypes were performed.

Eligibility criteria: Inclusion Criteria:

* 3 female siblings with identical complaints of no menarche

Exclusion Criteria:

* patients outside this family.

Primary outcomes:
measure: Karyotype
timeFrame: 1 month after testing
Secondary outcomes:
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Department of Obstetrics and Gynecology, Universitas Padjadjaran
Study officials:
References:
citation: Marzuki NS, Idris FP, Kartapradja HD, Harahap AR, Batubara JRL. Characterising SRD5A2 Gene Variants in 37 Indonesian Patients with 5-Alpha-Reductase Type 2 Deficiency. Int J Endocrinol. 2019 Dec 1;2019:7676341. doi: 10.1155/2019/7676341. eCollection 2019.
citation: Walter KN, Kienzle FB, Frankenschmidt A, Hiort O, Wudy SA, van der Werf-Grohmann N, Superti-Furga A, Schwab KO. Difficulties in diagnosis and treatment of 5alpha-reductase type 2 deficiency in a newborn with 46,XY DSD. Horm Res Paediatr. 2010;74(1):67-71. doi: 10.1159/000313372. Epub 2010 Apr 16.
Clinical trial NCT01695980: Laryngeal Mask Airway in Pediatric Adenotonsillectomy
Official title: Laryngeal Mask Airway in Pediatric Adenotonsillectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Tonsillitis
Keywords: adenotonsillectomy
Lead sponsor: Eastern Virginia Medical School
Sponsor class: OTHER
First posted: 2012-09-28
Enrollment: 81
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will compare how often the tubing kinks when a LMA (laryngeal mask airway) with modified retractor is used compared to use of an endotracheal tube (ETT) and non modified retractor is used.

Detailed description: The laryngeal mask airway (LMA)is a device used to secure the airway of patients during general anesthesia. This device is routinely used for anesthesia in elective head and neck surgeries, including adenotonsillectomy. In this study, the efficacy of the LMA will be studied as it pertains to operative times and cost.

The child will be randomized into either the LMA group or the ETT group.

Eligibility criteria: Inclusion Criteria:

* requiring adenotonsillectomy for Obstructive sleep apnea or chronic tonsillitis between the ages of 2-16

Exclusion Criteria:

* children with BMI \>35
* unwillingness to comply with study procedures
* children with craniofacial anomalies/abnormalities which will interfere with mask placement
* children under 2 or over 16

Primary outcomes:
measure: To determine the number of participants with adverse events with use of LMA and ETT during adenotonsillectomy.
timeFrame: one year
Secondary outcomes:
measure: To determine total length of procedure and recovery time with use the LMA.
timeFrame: One year
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Children's Hospital of the King's Daughters
state: Virginia
Study officials:
affiliation: Eastern Virginia Medical School
name: Christina Baldassari, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02850380: Spatial Orientation and Motor Skills: How to Flip Switches "Down" in Weightlessness?
Official title: Spatial Orientation and Motor Skills: How to Flip Switches "Down" in Weightlessness?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
Collaborators: name: Novespace
First posted: 2016-08-01
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of the study is to investigate spatial orientation in weightlessness as it manifests not in perception but rather in motor performance by direction and reaction time of flip switch.

Hypotheses are that flip switch:

1. will be biased towards visual allocentric cues when those are available;
2. will be biased towards the egocentric reference when tactile cues are added;
3. will be dominated by egocentric cues when visual cues are not available;
4. will be delayed and more variable when confirmatory gravitational cues are absent;
5. will be faster and more reliable in absence of conflicting gravitational cues, and even more so when tactile cues are added;
6. The difference will be more pronounce when tested under Dual-task condition


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers (men or women)
* Aged from 20 to 65
* Affiliated to a Social Security system and, for non-French resident, holding a European Health Insurance Card (EHIC)
* Who accepted to take part in the study
* Who have given their written stated consent
* Who has passed a medical examination similar to a standard aviation medical examination for private pilot aptitude (JAR FCL3 Class 2 medical examination). There will be no additional test performed for subject selection.

Subjects will be staff member of the team or of other teams participating in the parabolic flight campaign

Exclusion Criteria:

* Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated
* Person who has already participated in a parabolic flight
* Pregnant women

Primary outcomes:
measure: reaction time of flip switch measured with a chronometer
timeFrame: baseline
measure: Direction of flip switch measured with the circular instrument panel
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen CHU
Study officials:
affiliation: CHU CAEN
name: Pierre DP Denise, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05950880: Effect of High Intensity Exercises in Treatment of Patients With Shoulder Impingement Syndrome
Official title: Effect of Adding High Intensity Exercises to Conventional Physical Therapy in Treatment of Athlete Patients With Shoulder Impingement Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Impingement Syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-07-18
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purposes of the study

To investigate the effect of adding High-Intensity Exercises to conventional physical therapy in patients with Shoulder Impingement Syndrome

Detailed description: Patients will be randomized into either High-intensity shoulder exercise group or Conventional physical therapy group. Patients will receive the intervention for six weeks. Outcomes will be assessed at baseline and post-intervention.

Eligibility criteria: Inclusion Criteria:

1. Athletic patients
2. Age of the patients between 18 - 35 years
3. Unilateral shoulder pain more than 3 months.
4. Positive Hawkins test.
5. Positive empty or full cane test.
6. Pain at night or incapable of lying on the shoulder.
7. Pain with active shoulder elevation in the scapular plane.
8. History of pain in the C5-C6 dermatome.
9. Pain with palpation of the rotator cuff tendons.
10. The patient had pain with resisted isometric abduction

Exclusion Criteria:

1. History of shoulder instability (positive Sulcus sign, positive apprehension test, and history of shoulder dislocation).
2. Clinical sign of cervical radiculopathy.
3. History of acromio -clavicular pain.
4. Rheumatoid Arthritis.
5. Adhesive capsulitis.
6. Tumors
7. Labrum lesions
8. Capsular or ligamentous tears or avulsions
9. Cartilage lesions

Primary outcomes:
measure: pain and function
timeFrame: Change from Baseline pain and function at 6 weaks
measure: Supraspinatus muscle thickness
timeFrame: Change from Baseline Supraspinatus muscle thickness at 6 weaks
Secondary outcomes:
measure: Sub acromial space (Acromiohumeral distance).
timeFrame: Change from Baseline Sub acromial space at 6 weaks
measure: External and internal rotators muscle strength.
timeFrame: Change from Baseline External and internal rotators muscle strength at 6 weaks
measure: supuraspinatus muscle strength
timeFrame: Change from Baseline supuraspinatus muscle strength at 6 weaks
measure: shoulder performance
timeFrame: Change from Baseline shoulder performance at 6 weaks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: facult of physical therapy,MTI
Study officials:
affiliation: Cairo University
name: Abdallah Gamiel, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02495480: Disposable Sheathed Gastroscopic System for Cecal Intubation
Official title: A Novel Disposable Sheathed Gastroscopic System for Cecal Intubation：Safety and Efficacy in Unsedated Colonoscopies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cecal Intubation Success Rate
Keywords: disposable sheath
intubation
colonoscopy
Lead sponsor: General Hospital of Beijing PLA Military Region
Sponsor class: OTHER
First posted: 2015-07-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: A novel disposable sheathed gastroscope system has been shown to be safe and more efficient in clinical practice during gastroscopy. This novel disposable sheathed endoscope system could effectively prevent cross-infection by simply taking off the contaminated sheath after examination of a patient and placing a new sheath on the endoscope. In this way, investigators can save the endoscopic reprocessing time and also decrease the need for endoscopic cleaning and disinfecting equipment.

Participants may think that placing a new sheath on the endoscope can decrease the success rate of cecal intubation in patients undergoing screening colonoscopy. With a new sheath on the endoscope during scope insertion can probably increases distension of the colonic lumen and loop formation. The probable adhesion may increase the discomfort of investigators and participants. But a previous clinical study by investigators' team showed that the participants' feeling were no significant difference (Z = -1.783, P = 0.075) between sheathed and conventional groups. No significant differences were observed in optical clarity, or pathology detection rate. There were no complications, and no microbial contamination was detected. Based on this study, investigators hypothesize that compared with conventional group, placing a new sheath on the endoscope does not significantly reduce the success rate of cecal intubation in average patients.

The aim of the study is to compare the outcome of colonoscopy placing a new sheath on the endoscope versus the conventional method in average participants. The primary outcome is cecal intubation success rate. The secondary outcomes include cecal intubation time, maximum pain score during colonoscopy, overall pain score after colonoscopy and adenoma detection rate.


Eligibility criteria: Inclusion Criteria:

* patients accepted sedated colonoscopy

Exclusion Criteria:

* a request for sedation/analgesia at the start of the procedure
* previous colorectal surgery
* declining to provide informed consent
* advanced comorbidity
* coagulopathy or anticoagulant medication administered
* failure to comply with the recommended bowel preparation regimen.

Primary outcomes:
measure: Cecal intubation success rate
timeFrame: up to ten months
Secondary outcomes:
measure: Pain according to a 10-point pain scale
timeFrame: up to ten months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02895880: A Risk Assessment Tool to Increase Statin Use Among High Risk Cancer Survivors: Development and Pilot Testing
Official title: A Risk Assessment Tool to Increase Statin Use Among High Risk Cancer Survivors: Development and Pilot Testing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer Survivors
Statin Use Among High Risk Survivors
Keywords: Communication Tool
Cancer Survivors
Increase Statin
16-1128
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2016-09-12
Enrollment: 49
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Survivorship clinic

Brief summary: The purpose of this study is to collect initial data on what survivors of childhood, adolescent, and young adult cancer think of how information about statins is communicated. Statins are medications that lower cholesterol. The results of this study will be used to improve the communication about statins. This is to aid patients and their providers in making health care decisions together, also known as shared decision making.


Eligibility criteria: Inclusion Criteria:

* English speaking
* A personal history of cancer, tumor, or a related illness
* Followed in the Adult Long Term Follow Up Program
* Received ≥ 2000 cGy radiation to the heart/chest
* ≥Ten years post-radiation therapy to the heart/chest
* Age ≥ 25 years old

Exclusion Criteria:

* Evidence of active progression of disease or recurrence
* Neurocognitive deficits that impair ability to give informed consent
* Current use of a statin
* Diagnosis of another primary cancer for which the patient is currently undergoing radiation therapy chemotherapy, or bone marrow transplant
* Diagnosis of CVD with or without current statin use

Primary outcomes:
measure: number of patients who initiated statins after the office visit
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Nirupa Raghunathan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06947980: Study of CM512 in Patients With Moderate-to-Severe Atopic Dermatitis
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of CM512 in Patients With Moderate-to-Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Keymed Biosciences Co.Ltd
Sponsor class: INDUSTRY
First posted: 2025-04-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Phase 2 study designed to evaluate the efficacy and safety of CM512 in adult patients with moderate-to-severe Atopic Dermatitis (AD).


Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of moderate-to-severe AD for at least 1 year according to the American Academy of Dermatology's consensus criteria prior to the screening visit meeting all of the following criteria:
* EASI≥16 at Screening and Baseline visits;
* Investigator's Global Assessment (IGA) score of≥3 at Screening and Baseline visits;

  * 10% Body Surface Area (BSA) of AD involvement at Screening and Baseline visits;
* Mean of weekly Pruritus Numeric Rating Scale (NRS) severity score≥4 at Baseline;

Exclusion Criteria:

* Not enough washing-out period for previous therapy.
* Concurrent disease/status which may potentially affect the efficacy/safety judgement.
* Organ dysfunction.
* pregnancy.
* Other.

Primary outcomes:
measure: Percent change from Baseline in Eczema Area and Severity Index (EASI) at Week 24
timeFrame: Baseline, Week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's hospital
Study officials:
affiliation: Peking University People's Hospital
name: Jianzhong Zhang
role: PRINCIPAL_INVESTIGATOR
References: