louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03726541: Hemodynamic Effects of Physiotherapy in the Early Postoperative Period
Official title: Hemodynamic Effects of Physiotherapy in the Early Postoperative Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physiotherapy
Postoperative
Lung Diseases
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2018-10-31
Enrollment: 72
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
Primary purpose: SCREENING

Brief summary: Physiotherapy will be applied to the patients who undergo thoracotomy operation after 24 hours of intensive care stay. Physiotherapy program includes breathing exercises, incentive spirometer training, ambulation. Oxygen saturation, heart rate and blood pressure values will be recorded before and after the training session. Changes in the follow-up parameters will be discussed.


Eligibility criteria: Inclusion Criteria

* Between 18-75 age
* Hemodynamically stable
* Being conscious

Exclusion Criteria:

* Excessive pain
* Neurological complications
* Posttraumatic and musculoskeletal problems to prevent exercise
* Do not want to be included in the study
* Fever above 38 degrees

Primary outcomes:
measure: Change from baseline oxygen saturation
timeFrame: 30 minutes
measure: Change from baseline hearth rate response.
timeFrame: 30 minutes
measure: Change from baseline systolic and diastolic blood pressure response.
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Yedikule Chest Disease Hospital
state: Zeytinburnu
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Arif Balcı
role: STUDY_CHAIR
References:
Clinical trial NCT05763641: TAD After Chemotherapy in Locally Advanced Breast Cancer
Official title: Target Axillary Dissection After Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sentinel Lymph Node
Breast Cancer
Locally Advanced
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
First posted: 2023-03-10
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Locally advanced breast cancer tumours (cN2 or T4) after Neoadjuvant chemotherapy

Brief summary: This is an observational study to validate target axillary dissection (TAD) in locally advanced tumors (cN2 and/or cT4).

Detailed description: The procedure will consist of marking the pathological lymph node with 1 clip before the start of neoadjuvant chemotherapy (NAC) and performing surgery after completing the NAC. The TAD will include the exeresis of the node marked with a clip, and of the sentinels marked with technetium and/or patent blue, seeking to obtain at least 3 lymph nodes. Subsequently, the axillary lymphadenectomy will be completed to identify the false negative rate. An initial analysis will be carried out with the first 30 cases, and if there are more than 2 false negative cases, it will be completed until 81 cases of TAD without associated disease are obtained.

Eligibility criteria: Inclusion Criteria:

* Axillary lymph node metastasis proven by cytology
* Clinical or radiological N2a (at least 4 suspicious lymph nodes on axillary ultrasound at diagnosis)
* Extensive T4 subsidiary to axillary lymphadenectomy according to current clinical criteria
* Neoadjuvant chemotherapy

Exclusion Criteria:

* cN3 verified by imaging tests
* N2 due to internal mammary involvement (N2b).
* Tumors whose surrogate molecular subtype is luminal A.
* Patients undergoing neoadjuvant endocrine therapy
* Patients with local recurrences and metastatic tumors.

Primary outcomes:
measure: TAD validation in locally advanced breast cancer
timeFrame: 3 years
Secondary outcomes:
measure: Ultrasound validity to evaluate axillary response after NAC
timeFrame: 3 years
measure: MRI validity to evaluate axillary response after NAC
timeFrame: 3 years
Other outcomes:
Locations:
city: Hospitalet de Llobregat
country: Spain
facility: Hospital de Bellvitge
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Clínico y Provincial de Barcelona
Study officials:
affiliation: Instituto de Investigación Biomédica de Bellvitge (IDIBELL)
name: amparo Garcia-Tejedor, MDPhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01023841: Safety and Efficacy of Bimatoprost Solution in Treating Eyelash Loss or Hypotrichosis in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Eyelash Hypotrichosis
Alopecia Areata
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2009-12-02
Enrollment: 71
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of bimatoprost solution 0.03% once daily application to the upper eyelid margins compared with vehicle in treating eyelash loss or hypotrichosis (inadequate or not enough eyelashes) in children.


Eligibility criteria: Inclusion Criteria:

* Children who have inadequate eyelashes or have lost their eyelashes as a result of chemotherapy treatment, who completed their chemotherapy (intensive treatment) at least 4 weeks before starting the study, are considered to be at low risk for relapse of their cancer, and are well enough to complete the study
* Children who have minimal to moderate inadequate eyelashes due to alopecia areata
* Adolescents between the ages of 15-17 years who have minimal to marked inadequate eyelashes

Exclusion Criteria:

* Any eye disease or abnormality, eye surgery, permanent eyeliner, eyelash implants.
* Semi-permanent eyelash tint, dye or eyelash extension application within 3 months
* Use of over the counter eyelash growth products within 6 months.
* Use of prescription eyelash growth products (eg, Latisse®)
* Any eye condition that would prevent required ophthalmology exams

Primary outcomes:
measure: Percentage of Participants With Adverse Events
timeFrame: 5 Months
measure: Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Global Eyebrow Assessment (GEA) Score
timeFrame: Baseline, Month 4
Secondary outcomes:
measure: Change From Baseline Upper Eyelash Length as Measured by Digital Image Analysis (DIA)
timeFrame: Baseline, Month 4
measure: Change From Baseline in Upper Eyelash Thickness as Measured by DIA
timeFrame: Baseline, Month 4
measure: Change From Baseline in Upper Eyelash Darkness as Measured by DIA
timeFrame: Baseline, Month 4
Other outcomes:
Locations:
city: Newport Beach
country: United States
state: California
city: São Paulo
country: Brazil
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Borchert M, Bruce S, Wirta D, Yoelin SG, Lee S, Mao C, VanDenburgh A. An evaluation of the safety and efficacy of bimatoprost for eyelash growth in pediatric subjects. Clin Ophthalmol. 2016 Mar 10;10:419-29. doi: 10.2147/OPTH.S89561. eCollection 2016.
Clinical trial NCT02418741: Head Position for Endotracheal Intubation
Official title: The Degree of Neck Flexion Does Not Influence on the Laryngeal View and Discomfort During Endotracheal Intubation in Adult Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation; Difficult
Lead sponsor: National Medical Center, Seoul
Sponsor class: OTHER
First posted: 2015-04-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to investigate whether degree of neck flexion affect on laryngeal view and discomfort during endotracheal intubation in adult patients.

Detailed description: The neck flexion using a 8 to 10 cm head elevation has been suggested to align laryngeal, pharyngeal and oral axes and facilitate endotracheal intubation by direct laryngoscopy. There have been scarce clinical studies about the appropriate degree of neck flexion for endotracheal intubation. In the present study, the laryngeal view and physician's discomfort during endotracheal intubation were evaluated according to the two degrees of neck flexion(4 cm vs 8 cm) using a 4 or 8 cm height of pillows, respectively, in adult patients.

Eligibility criteria: Inclusion Criteria:

* Elective operation time ≤2hrs
* American Society of Anesthesiologist, Physical Status 1 or 2
* age ; 18 - 90 years

Exclusion Criteria:

* patient has upper respiratory infection symptoms
* limited mouth opening
* teeth problems
* expecting difficult airway
* congenital heart disease
* patient has a possibility of aspiration pneumonia

Primary outcomes:
measure: Laryngeal view as index of ease of insertion
timeFrame: one year
Secondary outcomes:
measure: Discomfort of anesthesiologist during endotracheal intubation
timeFrame: one year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: National Medical Center
state: Junggu
Study officials:
affiliation: National medical center
name: Mija Yun, staff
role: STUDY_DIRECTOR
References:
Clinical trial NCT05715541: Inr Tracking Coumadin Use With Phone App
Official title: Inr Tracking With Face-To-Face And Phone App: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Warfarin
Mobile Applications
Lead sponsor: Muhammed Onur Hanedan
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study aims to compare the INR values of the patients followed by face-to-face and telephone applications.

Detailed description: Warfarin has a narrow therapeutic window. Maintaining the patient's international normalized ratio (INR) within the predefined therapeutic range is one of the main challenges of warfarin treatment. This study was designed as a randomized controlled experiment. Twelve patients living in a distant place were assigned to the experimental group, and 12 patients living nearby and followed in the outpatient clinic were assigned to the control group. A Patient Information Form and the Adherence to Refills and Medications Scale were used to collect data.

Eligibility criteria: Inclusion Criteria:

* at least 18 years old, using a smartphone, not having a psychiatric illness or treatment, and agreeing to participate

Exclusion Criteria:

* requiring medical examination, not using a smartphone, having a psychiatric illness or treatment, and not agreeing to participate

Primary outcomes:
measure: Comparison of the Knowledge Levels of the Groups on the Use of Coumadin
timeFrame: It ranges from 6 months to 1 year
measure: Comparison of INR Control and Drug Compliance Values by Groups
timeFrame: It ranges from 6 months to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Ahi Evren Göğüs Kalp ve Damar Cerrahisi Eğitim ve Araştırma Hastanesi
Study officials:
affiliation: MD, Associate Professor1
name: Muhammet Onur HANEDAN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03263741: Exploratory Study on the Paclitaxel + S-1 + Oxaliplatin (PSOX) for Locally Advanced or Advanced Gastric Cancer
Official title: Exploratory Study on the Efficiency and Safety of Paclitaxel + S-1 + Oxaliplatin Chemotherapy in the Patients With Locally Advanced or Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: Paclitaxel
S-1
Oxaliplatin
Efficiency
safety
Lead sponsor: Affiliated Hospital of Qinghai University
Sponsor class: OTHER
First posted: 2017-08-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Explore the Efficiency and Safety of Paclitaxel + S-1 + Oxaliplatin (PSOX) Chemotherapy in the Patients with Locally Advanced or Advanced Gastric Cancer

Detailed description: To assess the Efficiency and safety of Paclitaxel + S-1 + Oxaliplatin(PSOX) in the Patients with Locally Advanced or Advanced Gastric Cancer

Eligibility criteria: Inclusion Criteria:

1. Histopathology or cytopathology proven gastric cancer or gastroesophageal adenocarcinoma;
2. Locally advanced, or recurrent, or metastasis disease；
3. Chemotherapy-naive or disease progress at least 6 months after adjuvant chemotherapy completed;
4. Life expectancy of at least 3 months;
5. ECOG score 0-1;
6. Age: 18\~70 years old;
7. Normal hemodynamic indices before the recruitment (including blood cell count and liver/kidney function). For example: WBC\>4.0×109/L, NEU \>1.5×109/L, PLT\>100×109/L, BIL\<1.5 times of upper limit of normal reference value, ALT and AST\<2.5 times of upper limit of normal reference value, and CRE\<1.2mg/dl;
8. Good cardiac function before the recruitment, no seizure of myocardial infarction in past half year, and controllable hypertension and other coronary heart diseases;
9. Not concomitant with other uncontrollable benign diseases before the recruitment (e.g. the infection in the lung, kidney and liver);
10. Not participating in other study projects before and during the treatment;
11. Voluntarily signed the informed consent.

Exclusion Criteria:

1. Previously treated with first-line chemotherapy;
2. Allergy to the drugs in this protocol;
3. Pregnant or lactating women;
4. Women at childbearing age and of pregnancy desire during the study.

Primary outcomes:
measure: Objective response rate(ORR)
timeFrame: 2 years
Secondary outcomes:
measure: Progression-free survival(PFS)
timeFrame: 2 years
measure: Overall survival(OS)
timeFrame: 2 years
measure: Disease control rate(DCR)
timeFrame: 2 years
Other outcomes:
Locations:
city: Xining
country: China
facility: Affiliated Hospital of Qinghai University
state: Qinghai
Study officials:
affiliation: Affiliated Hospital of Qinghai University
name: Jiuda Zhao, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06626841: Assessment of Pelvic Floor Strength Variables in Female Nulliparous Athletes
Official title: A Functional Fitness Training Workout Significantly Affects Pelvic Floor Strength and Muscle Activation in Female Nulliparous Athletes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Floor Muscle Weakness
Strength
Muscle Tone
Lead sponsor: Universidad Politecnica de Madrid
Sponsor class: OTHER
First posted: 2024-10-04
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents of Madrid, members of a FFT facility.

Brief summary: Functional Fitness Training (FFT) is a modality that seeks to improve physical fitness and performance within several functional tasks by conducting a variety of training activities such as aerobic and metabolic conditioning, resistance training, and high impact exercises. Although there are many benefits of FFT for improving fitness and body composition, their effects on the pelvic floor are not clear, as high-impact exercises performed in FFT have been shown to cause an increase in intra-abdominal pressure. When these exercises are performed repeatedly, fatigue can occur within the pelvic floor muscles (PFM), which can increase the risk of developing pelvic floor dysfunctions. However, currently little is known about how FFT activities acutely affect the PFM and whether such training regimes may contribute to long-term urinary incontinence in female FFT athletes. Therefore, this study aimed to analyse the acute effects of a FFT.workout on pelvic floor strength and muscle activation in nulliparous female FFT athletes. It is hypothesized that both strength and PFM activation of the female athletes would be reduced after a FFT workout due to PFM fatigue.


Eligibility criteria: Inclusion Criteria:

* Nulliparous
* Have been practicing FFT or weightlifting for at least 2 years
* Train a minimum of 3 days/week that did not include pelvic floor exercises
* Have no medical contraindications or previous pelvic floor surgeries

Exclusion Criteria:

* Any criterion that fails to meet the inclusion criteria

Primary outcomes:
measure: Muscle activation
timeFrame: Change from baseline to the end of the workout, around 1 hour.
measure: Strength
timeFrame: Change from baseline to the end of the workout, around 1 hour.
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Politécnica de Madrid
Study officials:
References:
Clinical trial NCT01571141: Polyhexamethylene Biguanide Increases the Regression Rate of Human Papillomavirus (HPV) Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HPV Infection
Keywords: HPV
polyhexamethylene biguanide
intraepithelial lesions
regression rate
Lead sponsor: AGUNCO Obstetrics and Gynecology Centre
Sponsor class: OTHER
First posted: 2012-04-05
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no

Brief summary: Human papillomavirus (HPV) infection is a worldwide problem strictly linked to the development of cervical cancer. Persistence of the infection is one of the main factors responsible for the invasive progression and women diagnosed with intraepithelial squamous lesions are referred for further assessment and surgical treatments which are prone to complications. Despite this, there are several reports on the spontaneous regression of the infection.

In this study the investigators will evaluate the effectiveness of a long term polyhexamethylene biguanide (PHMB)-based local treatment in improve the viral clearance reducing the time exposure to the infection and avoiding the complications associated with the invasive treatments currently available.

Women diagnosed with HPV infection were randomly assigned to receive six months of treatment with a PHMB-based gynaecological solution (Monogin®) or to remain untreated for the same period of time.

The administration of Monogin® has been performed every three days for fifteen days and then every fifteen days for the subsequent six months.


Eligibility criteria: Inclusion Criteria:

* pathologic Pap smear
* positive "high risk" HPV DNA test
* positive colposcopy examination

Exclusion Criteria:

* patients who had undergone wart therapy in the previous six months
* pregnancy
* invasive disease
* immunosuppression
* previous HPV vaccination

Primary outcomes:
measure: Number of patients with no HPV infection
Secondary outcomes:
Other outcomes:
Locations:
city: Messina
country: Italy
facility: Consultorio Familiare Terme Vigliatore, A.S.P. 5
Study officials:
References:
citation: Zanotti KM, Belinson J. Update on the diagnosis and treatment of human papillomavirus infection. Cleve Clin J Med. 2002 Dec;69(12):948, 951-5, 956 passim. doi: 10.3949/ccjm.69.12.948.
citation: Hubner NO, Kramer A. Review on the efficacy, safety and clinical applications of polihexanide, a modern wound antiseptic. Skin Pharmacol Physiol. 2010;23 Suppl:17-27. doi: 10.1159/000318264. Epub 2010 Sep 8.
citation: Marelli G, Papaleo E, Origoni M, Caputo L, Ferrari A. Polyhexamethylene biguanide for treatment of external genital warts: a prospective, double-blind, randomized study. Eur Rev Med Pharmacol Sci. 2005 Nov-Dec;9(6):369-72.
citation: Gentile A, Gerli S, Di Renzo GC. A new non-invasive approach based on polyhexamethylene biguanide increases the regression rate of HPV infection. BMC Clin Pathol. 2012 Sep 25;12:17. doi: 10.1186/1472-6890-12-17.
Clinical trial NCT02309541: Evaluation of New Feedback Canceller for Carina™ Implant
Official title: Evaluation of a New Feedback Canceller Algorithm for Patient With Moderate to Severe Hearing Loss Implanted With a Fully Implantable Carina™ Medical Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Keywords: middle ear implant
feedback manager
Sound quality
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
First posted: 2014-12-05
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate audio quality benefit for the patient implanted with a Cochlear or Otologics Carina implant with the new firmware (feedback canceller algorithm) whatever the patient environment is and to evaluate the functional gain and speech understanding benefit for the patient upon the firmware used (new and reference firmware). The new firmware aims to adapt automatically for feedback cancellation without prior calibration.


Eligibility criteria: Inclusion Criteria:

* successfully implanted with a commercial available CE-labelled implant device, resulting in measurable open set speech understanding
* native speaker in the language used to assess their clinical performance, i.e. French

Exclusion Criteria:

* unwillingness or inability to comply with all of the investigational requirements
* additional handicaps that would prevent or restrict participation in the audiological evaluations

Primary outcomes:
measure: Sound quality benefit assessed via subjective patient evaluation with Abbreviated Profile of Hearing Aid Benefit questionnaire
timeFrame: 1 month
measure: Sound quality benefit assessed via subjective patient evaluation with Abbreviated Profile of Hearing Aid Benefit questionnaire
timeFrame: 2 months
measure: Sound quality benefit assessed via subjective patient evaluation with Abbreviated Profile of Hearing Aid Benefit questionnaire
timeFrame: 3 months
measure: Sound quality benefit assessed via subjective patient evaluation with Abbreviated Profile of Hearing Aid Benefit questionnaire
timeFrame: 4 months
Secondary outcomes:
measure: Improvement in speech understanding assessed via speech audiometry in noise
timeFrame: 1 month
measure: Improvement in speech understanding assessed via speech audiometry in noise
timeFrame: 2 months
measure: Improvement in speech understanding assessed via speech audiometry in noise
timeFrame: 3 months
measure: Improvement in speech understanding assessed via speech audiometry in noise
timeFrame: 4 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hôpital Nord
state: Bouches-du-Rhône
city: Lyon
country: France
facility: Hôpital Edouard Herriot
state: Rhône
city: Pierre-Bénite
country: France
facility: CHU Lyon Sud
state: Rhône
Study officials:
affiliation: Hospices Civils de Lyon
name: Stéphane Tringali, Prof
role: PRINCIPAL_INVESTIGATOR
References: