louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03108534: A Study to Evaluate the Onset of Relief From Methacholine-induced Bronchoconstriction With CHF1535 NEXThaler in Asthmatic Patients.
Official title: A Single Dose, Randomised, Double Blind, Double Dummy, Placebo Controlled, 3-way Crossover Clinical Study, Comparing the Onset of Relief From Methacholine-induced Bronchoconstriction With CHF1535 100/6 µg NEXThaler® Versus CHF1535 100/6 µg pMDI in Asthmatic Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2017-04-11
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The clinical trial is designed to evaluate the non-inferiority of CHF1535 100/6 µg NEXThaler versus CHF1535 100/6 µg pMDI on the onset of relief from methacholine-induced bronchospasm, in terms of pulmonary function (i.e. change in Forced Expiratory Volume in the 1st second, FEV1, from baseline to 5 min after study drug intake) in asthmatic patients.


Eligibility criteria: Inclusion Criteria:

* Informed consent form obtained
* Minimum required Peak Inspiratory Flow (PIF) to activate NEXThaler
* Pre-bronchodilator FEV1 of at least 65%
* Positive response to methacholine challenge test
* Previous treatment with low-medium doses of Inhaled Corticosteroids (ICS) or ICS/Long-acting beta2-agonist (LABA) as per Global Initiative for Asthma (GINA) 2016 guidelines
* For females: non-pregnant, non-lactacting and using highly effective contraceptive methods.

Exclusion Criteria:

* Clinically relevant and uncontrolled concomitant diseases
* Abnormal clinically relevant ECG
* Presence of aortic aneurism
* Uncontrolled hypertension
* Intake of non-permitted concomitant medications
* Participation in another clinical trials in the previous 8 weeks
* Seasonal variation in asthma
* Recent occurrence of asthma exacerbations
* Hypersensitivity to any product used in the trial, including excipients
* Heavy caffeine drinkers
* History of alcohol/drug abuse
* Smokers

Primary outcomes:
measure: Change in FEV1 5-min post-dose
timeFrame: 5 min post-dose
Secondary outcomes:
measure: Change in FEV1 other time points
timeFrame: Up to 30 min post-dose
measure: FEV1 AUC0-10min
timeFrame: From dosing to 10 min post-dose
measure: Time to recovery in FEV1
timeFrame: From dosing to 30 min post-dose
measure: Change in Borg scale
timeFrame: Up to 30 min post-dose
measure: Time to recovery in Borg scale
timeFrame: Up to 30 min post-dose
Other outcomes:
Locations:
city: Dundee
country: United Kingdom
facility: University of Dundee
city: London
country: United Kingdom
facility: Hammersmith Medicines Research
city: Manchester
country: United Kingdom
facility: Medicines Evaluation Unit
Study officials:
References:
Clinical trial NCT03035734: Evaluate the Bioavailability Between 2 BMS-986141 Formulations in Healthy Participants
Official title: A Randomized Study to Evaluate the Bioavailability of BMS-986141 From a Form B Tablet Formulation Relative to the Form A Reference Tablet in Healthy Participants
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-01-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Open label, randomized, 4-period crossover study with single doses of BMS-986141 given to healthy female subjects of non-childbearing potential and healthy males.


Eligibility criteria: Inclusion Criteria:

* Healthy participants as determined by no significant deviations in normal medical and surgical history and assessments
* Body mass index 18.0 kg/m2 to 32.0 kg/m2
* females must be of non-childbearing potential

Exclusion Criteria:

* known bleeding or coagulation disorders
* acute or chronic medical illness
* history of nausea or chronic diarrhea that lasts over 4 weeks
* history of periodontal disease or gingivitis which required treatment
* other exclusion criteria may apply

Primary outcomes:
measure: Evaluate the bioavailability between BMS-986141 Form B tablet compared to the Form A reference tablet
timeFrame: 4 weeks
Secondary outcomes:
measure: Further characterize safety and tolerability of BMS-986141 by assessing adverse events and other physical assessments throughout study conduct
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT02985034: Safety Margin Assessment After RFA Using the Registration of Pre-ablation MRI and Post-ablation CT
Official title: Prospective Evaluation of Local Tumor Progression After Radiofrequency Ablation of Hepatocellular Carcinoma: Effectiveness of Immediate Second-Look Evaluation Using Pre-RFA MRI and Post-RFA CT Registration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HCC
Liver Tumor
Keywords: HCC
RFA
Liver tumor
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-12-07
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with liver tumor and referred to Radiology for RFA.

Brief summary: Magnetic resonance imaging (MRI) has been widely used for small liver lesion detection and characterization. In patients who undergo RFA, MRI is often performed before RFA, whereas immediate technical success is usually assessed by CT. Conventional visual assessment of two modalities may be more challenging than being anticipated, because acquisition position, respiration, and spatial resolution differ between the two. Therefore, the study purpose is to evaluate the results of software-assisted ablative margin assessment using registration of different pre-and post-RFA modalities compared with the conventional method of side-by-side MRI-CT comparison in patients with HCCs.


Eligibility criteria: Inclusion Criteria:

* patients (≥ 18 years) who were referred to our radiology department for liver tumor RFA
* patients who had liver MR images of sufficient quality for pre-RFA evaluation within 30 days before RFA
* patients with 1-3 tumors (\<5 cm)

Exclusion Criteria:

* Child-Pugh class C
* any uncorrected coagulopathy
* hypersensitivity to iodine or other reasons that prevented the performance of post-RFA contrast-enhanced CT

Primary outcomes:
measure: Local tumor progression (LTP)
timeFrame: 60 months
Secondary outcomes:
measure: technique efficacy
timeFrame: 1 month after RFA
measure: immediate technical success on visual assessment
timeFrame: 1 day after RFA
measure: immediate technical success on registration-software assessment
timeFrame: 1 day after RFA
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jeong Min Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06458634: Weight Variation on Cop
Official title: Impact of Weight Variation on Cop Displacement During Unperturbed Standing Conditions in Adolescents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adolescent Overweight
Lead sponsor: Delta University for Science and Technology
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: They will be assigned into four group of equal numbers according to (BMI) body mass index for age percentile obese group (n=50), overweight group (n=50), underweight group (n=50) and normal group weight (n=50).

Brief summary: This study will be conducted to investigate the impact of variant weights in adolescents during unperturbed standing conditions.

Detailed description: 200 adolescents from both sexes will be assigned to this study. They will be selected randomly from a secondary school student and first level university students. They will be assigned into four group of equal numbers according to (BMI) body mass index for age percentile obese group (n=50), overweight group (n=50), underweight group (n=50) and normal group weight (n=50).The FREEMED platform and FREESTEP software were used to assess the following parameters for each subject:

1. Sway length (mm).
2. The Maximum (peak) Oscillation of COP.
3. The minimum Oscillation of COP.

Eligibility criteria: Inclusion criteria:

* Their age will be ranging from 16 to 18 years.
* The sample will be selected according to (BMI-for Age percentile) growth charts according to CDC (Centers for Disease Control and Prevention) (appendix-1) (NCHS, 2014)
* All participant will be free from any musculoskeletal deformities.
* All participant are free of peripheral neuropathic diseases.
* They have no visual or auditory or vestibular disorders.
* They will able to understand, follow and execute instructions included in the testing analysis procedures.

Exclusion criteria:

* All adolescent associated with any musculoskeletal deformities.
* All adolescent associated with any foot deformity.
* All adolescent had a previous foot orthopedic procedure.
* All adolescent has visual or auditory or vestibular disorder.
* All adolescent has peripheral neuropathy.
* Adolescent with morbid obesity BMI \>99th for age percentile (Barlow, 2007).

Primary outcomes:
measure: Sway length (mm)
timeFrame: through study completion, an average of 6 months
measure: The Maximum (peak) Oscillation of COP
timeFrame: through study completion, an average of 6 months
measure: The minimum Oscillation of COP
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gamasa
country: Egypt
facility: Amira Hussin Mohammed
Study officials:
References:
Clinical trial NCT03359434: Blood Pressure Measurement Methods and Prediction of Intracranial Hemorrhage After Thrombectomy in Stroke
Official title: Impact of Blood Pressure Measurement Methods for the Prediction of Intracranial Hemorrhage After Thrombectomy in Acute Stroke
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Acute Stroke
Blood Pressure
Cerebral Hemorrhage
Keywords: Acute Stroke
Blood Pressure
Cerebral Hemorrhage
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2017-12-02
Enrollment: 355
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: A monocentric, non-randomized, prospective study in which each patient is his/her own control.

The study investigates 2 methods of blood pressure measurement, within the first 24 hours after reperfusion, i) Continuous measurement of blood pressure with the Clearsight device (Edwards) and ii) intermittent blood pressure measurements with cuff.

Detailed description: Patients will be followed for 72 hours:

* inclusion after reperfusion: clinical evaluation with NIHSS (National Institute of Health Stroke Score) score, measurement of blood pressure.
* within 24 hours after reperfusion: blood pressure measurements
* at 24 hours: NIHSS score.
* Between 24 and 36 hours :cerebral scan (assessment of hemorrhagic transformations and cerebral infarction volumes).
* 72 hours after reperfusion: brain scanner in case of hyperdensity on the initial scanner

Eligibility criteria: Inclusion Criteria:

* Occlusion of internal carotid arteries or proximal middle cerebral arteries (segment M1).
* Reperfusion after a thrombectomy procedure (defined by a 2b-3 Thrombolysis In Cerebral Infarction (TICI) score).

Exclusion Criteria:

* Per-procedure hemorrhagic complications (prior to reperfusion)
* Known pregnancy

Primary outcomes:
measure: Occurence of intracranial hemorrhagic complications
timeFrame: 36 hours after baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique A de Rothschild
Study officials:
affiliation: Fondation Ophtalmologique A. de Rothschild
name: MAZIGHI Mikael, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05367934: The Effect of Therapeutic Treatment on Stress and Coping Stress
Official title: The Effect of Therapeutic Treatment Applied to Nursing Students on Perceived Stress and Stress Coping Behaviors: A Randomized Controlled Experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nurse's Role
Keywords: nursing, therapeutic touch, stress, coping stress, education
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2022-05-10
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a randomized controlled experimental study.
Primary purpose: TREATMENT

Brief summary: Nursing students are exposed to intensive theoretical and clinical applications throughout their academic education. During this educational process, students' stress increases and their coping behaviors are affected.

Detailed description: This study was conducted to determine the effects of therapeutic touch applied to nursing students on stress levels and coping behaviors. The nurses in the intervention group were given therapeutic touch for 15 minutes once a week for two weeks, and the patients in the control group did not receive any treatment other than their routine care.

Eligibility criteria: Inclusion Criteria:

* Over the age of 18, Maximum age 24 Volunteer to work, Nursing students who had not received touch therapy before were included in the study.

Exclusion Criteria:

* • Previous or current tactile therapy,

  * A therapeutic touch therapist,
  * Nursing students who did not volunteer for the study were not included in the study.

Primary outcomes:
measure: The Effect of Therapeutic Touch on Stress
timeFrame: Scales are filled after 3 days of application
measure: The Effect of Therapeutic Touch on Stress Coping Behaviors
timeFrame: Scales are filled after 3 days of application
Secondary outcomes:
Other outcomes:
Locations:
city: Osmani̇ye
country: Turkey
facility: Zehra Bayram
Study officials:
affiliation: Osmaniye Korkut Ata University
name: Hilal Kuşçu Karatepe, phD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05360134: Platelet Augmentation Using C. Papaya Leaf Extract in Live Donor Liver Transplantation
Official title: Efficacy and Safety of Platelet Augmentation Using Carica Papaya Leaf Extract in Live Donor Liver Transplantation Recipients - a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thrombocytopenia
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2022-05-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project is a pilot randomized controlled trial aimed at investigating the potential of Carica Papaya Leaf Extract, available in a marketed pill formulation, in increasing platelet counts in live donor liver transplant recipients. Carica Papaya leaf extract has shown positive results in increasing platelet counts in various medical conditions such as Dengue, Immune thrombocytopenic purpura and chemotherapy induced thrombocytopenia. Thrombocytopenia i.e. low platelet counts are a common occurrence in patients with chronic liver disease undergoing live donor liver transplant. It has been observed in previous studies that live donor liver transplant recipients who have persistent thrombocytopenia have significantly worse outcomes as compared to patients who have higher platelet counts. Positive results in this study lead to further studies in assessing the impact of platelet augmentation in live donor liver transplant recipients.


Eligibility criteria: Inclusion Criteria:

* All consenting adults who are planned to undergo live donor liver transplant with platelet counts less than or equal to 75000/μL preoperatively.

Exclusion Criteria:

* Patients who do not consent
* ALF \& ACLF
* Pediatric transplant recipients
* Allergic to papaya
* Preoperative platelet counts \>75,000/ μL
* Recent history of DVT

Primary outcomes:
measure: POD 7 Platelet Counts
timeFrame: 7th post-operative day
Secondary outcomes:
measure: Pre-operative platelet counts
timeFrame: 1 day prior to surgery
measure: Intra-operative blood loss and transfusion requirements
timeFrame: Day 0
measure: Incidence of Early allograft dysfunction
timeFrame: First 7 days following live donor liver transplant
measure: Incidence of prolonged post-operative drainage
timeFrame: First 14 days following live donor liver transplant
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver & Biliary Sciences
state: Delhi
Study officials:
affiliation: Institute of Liver & Biliary Sciences
name: Viniyendra Pamecha, FEBS
role: STUDY_DIRECTOR
References:
Clinical trial NCT02683434: Effects of Kinesio Taping on Postural Stability in Young Soccer Players
Official title: Effects of Kinesio Taping on Postural Stability in Young Soccer Players
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Increasing Performance of Healthy Athlete
Keywords: soccer
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2016-02-17
Enrollment: 62
Sex: MALE
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of our study is to investigate the effects of Kinesio Taping application, which is applied before the training period, on postural stability in young soccer players.


Eligibility criteria: Inclusion Criteria:

- Soccer players aged between 12-16

Exclusion Criteria:

- Players who had lower extremity injury previously

Primary outcomes:
measure: Change in Tetrax interactive balance system results
timeFrame: 45 minutes
Secondary outcomes:
measure: Change in Flir E5 Thermographic Camera results
timeFrame: 45 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Baskent University
Study officials:
References:
Clinical trial NCT00554034: Effect of Herbal Extracts on Gingival Inflammation
Official title: The Effect of Herbal Extracts on Inflammatory Enzymes in the Gingiva: a Dose Finding Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gingivitis
Keywords: gingivitis, localized treatment
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2007-11-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the minimal number of patches needed to get an effective response. Patients enrolled in the study will be given 1, 2, 3 or 4 patches in a cycle by the order they enter the study. After the first 20 patients \[5 cycles\], the effect of the number of patches will be tested. If there is no distinct reduction of beta glucuronidase in the GCF or of gingival index at the tested sites, more patients will be enrolled. Patients will be added one cycle at a time with results being tested and analyzed. The enrollemnts of patients will stop when a dose response will be noticed or 15 cycles have been reached.


Eligibility criteria: Inclusion Criteria:

1. Age 18 -75.
2. Severe localized gingival inflammation \[GI index 2 or greater

Exclusion Criteria:

1. Pregnancy or a wish to become pregnant during the study.
2. History of periodontal treatment within the last month.
3. Antibiotic treatment within the last month
4. Use of any antimicrobial mouthrinse within the last month.
5. Participation in another trial one month prior to the study.
6. Inability to behave compliant to the trial protocol by not placing all the patches given, or attending scheduled appointments.
7. Systemic Disease.
8. Patients using salicylate

Primary outcomes:
measure: To determine the correct dosing of the herbal Patch [THPP]
timeFrame: 3 months
Secondary outcomes:
measure: To demonstarte the safety of THPP on the gingival tissue and in the oral cavity
timeFrame: 3 months
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Jerusalem Perio Center
Study officials:
affiliation: Shaare Zedek Medical Center, Jerusalem, Israel
name: Menachem Oberbaum, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02977234: Hysteroscopic Tubal Occlusion Using Iso-Amyl 2-Cyano Acrylate (Amcrylate) in Patients With Hydrosalpinx
Official title: Hysteroscopic Tubal Occlusion With the Use of Iso Amyl-2-cyanoacrylate in Patients With Hydrosalpinx
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Hydrosalpinx
Infertility, Female
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2016-11-30
Enrollment: 40
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to assess the effectiveness of hysteroscopic tubal application of Iso Amyl-2-cyanoacrylate in occluding uterine tubes of infertile women with hydrosalpinx, which would make it an easy approach for occluding tubes with hydrosalpinx prior to IVF.

Detailed description: The study will be conducted according to the guidelines on human experimentation of the 1975 Declaration of Helsinki. For all patients after taking signed informed consent , transcervical hysteroscopic cannulation of the proximal one centimeter of fallopian tubes with hydrosalpinx, will be done using a 4 Fr, 42cm long, polyethylene ureteric catheter, where 0.5 ml of Iso Amyl-2-cyanoacrylate (AMCRYLATE®) will be injected.

All the surgical procedures will be performed without anesthesia, only premedication with an NSAID (e.g. NaproxenR) is given orally one hour before the procedure.

Each patient will be under close observation for the first 24 hours postprocedure for any signs of inflammation as abdominal pain, tenderness or fever and for the vital data.

Hysterosalpingography will be done for all patients 0ne and 3 months postinjection to confirm tubal occlusion prior to IVF.

Eligibility criteria: Inclusion Criteria:

Infertile women due to tubal factor with hydrosalpinx (unilateral or bilateral) prepared for IVF.

Exclusion Criteria:

1. Acute Pelvic inflammatory disease.
2. Intra uterine pathology

Primary outcomes:
measure: Fallopian tubal occlusion in patients with hydrosalpinx.
timeFrame: from one to three months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AIn Shams University Maternity Hospital
Study officials:
affiliation: Ain Shams University maternity hospital
name: Mohamed I Amer, MD
role: PRINCIPAL_INVESTIGATOR
References: