louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02331758: The Influence Factors of Ovarian Response in PCOS Patients With IVF-ET Treatment
Official title: The Influence Factors of Ovarian Response in Polycystic Ovary Syndrome Patients(PCOS) With In Vitro Fertilization and Embryo Transfer (IVF-ET) Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Beijing University Health Science Center
First posted: 2015-01-06
Enrollment: 1000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to explore the factors which affect ovarian response of PCOS patients with IVF-ET treatment, in order to provide predictive clinical index for the outcome of IVF-ET treatment in PCOS patients. After figuring out the controllable factors, researchers would be able to educate PCOS patients and improve the success rate while reducing the incidence of complications during the treatment at the same time.

Detailed description: Statistics of PCOS patients like age, BMI index and others would be collected. Through distributing questionnaires and query of past cases and collecting data recorded during the ovulation process like monitoring fluctuations in blood and ultrasonic monitoring results, researchers obtain the risk factors of the occurence of Ovarian Hyperstimulation Syndrome(OHSS) in IVF-ET treatment in PCOS patients and set up an OHSS prediction model, choose controllable factors in order to make up guidance and have intervention on patients with PCOS accordingly. The investigators expect this could improve the success rate of IVF-ET treatment in patients with PCOS, provide clues and assist to reduce the risk of the therapy.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of PCOS
* Long schedule time of Luteal phase
* Available to trace
* Normal Prolactin level with contraceptive treatment in recent 3 months

Exclusion Criteria:

* Unwilling to participate

Primary outcomes:
measure: oocyte number
timeFrame: 3 Month
Secondary outcomes:
measure: Success Rate
timeFrame: 3 Month
measure: OHSS complication
timeFrame: 3 Month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02568358: DNA-based Testing in BAL of Lung Transplant Recipients With Suspected Non-viral Lower Respiratory Tract Infection
Official title: DNA-based Testing in BAL of Lung Transplant Recipients With Suspected Non-viral Lower Respiratory Tract Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lower Respiratory Tract and Lung Infections
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2015-10-05
Enrollment: 48
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: Lung transplant recipients with suspected non-viral lower respiratory tract infection

Brief summary: Lung transplantation (LTx) , DNA-based testing.

Performance of DNA-based testing of bacterial and fungal pathogens in comparison to standard testing.

Experimental intervention: DNA-based testing of BAL fluid.

Detailed description: Cohen's kappa of any pathogen isolation by DNA-based testing vs. standard cultures in comparison to the final diagnosis of non-viral lower respiratory tract infection.

Eligibility criteria: Inclusion Criteria:

* patients after lung transplantation (single, double or combined)
* suspicion of non-viral lower respiratory tract infection as defined by at least 2 out of
* new onset of malaise
* new or progressive pulmonary infiltrate
* hypoxemia (SpO2/SaO2 \<92% or need for oxygen)
* temperature of 38 o C or above within 7 days
* purulent (yellow or greenish) sputum
* CRP of 30 mg/l or above
* PCT of 0,5 µg/l or above

Exclusion Criteria:

* no informed consent

Primary outcomes:
measure: Cohen's kappa of any pathogen isolation by DNA-based testing vs. standard cultures in comparison to the final diagnosis of non-viral lower respiratory tract infection
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hannover Medical School
name: Jens Gottlieb, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05014958: The Effect of Whole Body Vibration Training on Trunk Muscle Strength, Body Composition and Performance Parameters
Official title: The Effect of 6-week Whole Body Vibration Training on Trunk Muscle Strength, Body Composition and Performance Parameters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health, Subjective
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2021-08-20
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Whole body vibration (WBV) trainings are widely used in the field of sports medicine and rehabilitation. It is accepted that these trainings are a modality that can safely increase muscular activation and performance. However, although many exercise models have been tried on vibration platforms, a standard WBV program for trunk muscles has not been established. A total of 45 healthy individuals will be included in the study. Participants will be divided into 3 groups. Group 1 will perform exercises at 40hz frequency, group 2 will perform exercises at 25hz frequency on WBV. The control group will perform the same exercises at 0 Hz. The training will last 6 weeks and each session consists of 5 exercises.The training consists of basic core exercises that the individual does with his or her own body weight. Each training session is approximately 30 minutes. All participants will be evaluated using an isokinetic strength test with a Cybex dynamometer at the beginning and at the end of the additional treatment protocol. In addition, balance, body composition and anaerobic performance of individuals will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Healthy adults
* The age range should be between 20-35

Exclusion Criteria:

* Having an orthopedic problem
* Having orthopedic surgery in the last 6 months
* Doing daily exercise and sport

Primary outcomes:
measure: Muscle Strength Assesment
timeFrame: 20 Minutes
Secondary outcomes:
measure: Balance Assesment
timeFrame: 12 Minutes
measure: Body Composition Assesment
timeFrame: 3 Minutes
measure: Anaerobic Power Assesment
timeFrame: 5 Minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
affiliation: Gazi University
name: Ali Zorlular, Msc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01250158: Liver-PILP First-in-Man
Official title: First In-vivo Trial of the Liver Percutaneous Isolated Localized Perfusion (PILP) Set for the Treatment of Liver Metastases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Metastases
Keywords: Liver Percutaneous Isolated Localized Perfusion
PILP
Isolated Hepatic Perfusion
IHP
Liver metastases
Unresectable liver metastases of different etiologies
Lead sponsor: Medical Device Works NV SA
Sponsor class: INDUSTRY
Collaborators: name: Celerion
name: Cromsource
First posted: 2010-11-30
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to determine whether the PILP-kit can be safely used, within specific performance parameters, to isolate and perfuse the liver with a chemotherapeutic drug for the treatment of patients with unresectable liver metastases.

Detailed description: The objective of this Medical Device Study, is to demonstrate the feasibility of the liver PILP intervention.

The liver PILP intervention will be considered feasible if the procedure is demonstrated to be safe and the liver PILP kit performs according to specifications.

Eligibility criteria: Inclusion Criteria:

1. Subjects with ECOG (Eastern Cooperative Oncology Group) stages 0 or 1
2. Unresectable metastatic disease predominant in the liver

Exclusion Criteria:

1. More than 60 % tumor involved liver tissue
2. Abnormal vascular anatomy
3. Severe atherosclerosis
4. Dissection and/or thrombotic occlusion and/or aneurysm of the aorta, iliac or hepatic arteries
5. Short suprahepatic vena cava segment (\< 1.5 cm)
6. One or both jugular veins are occluded
7. Other severe, concomitant diseases regarding the subject status

Primary outcomes:
measure: To demonstrate the feasibility of the liver PILP intervention.
timeFrame: During intervention and up to 30 days post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: University Hospital Louvain Saint-Luc
city: Ghent
country: Belgium
facility: University Hospital Ghent
city: Leuven
country: Belgium
facility: University Hospitals Leuven, Catholic University
Study officials:
affiliation: University Hospitals Leuven, Catholic University
name: Eric Van Cutsem, Prof MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Ghent
name: Karen Geboes, Prof MD Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Ghent
name: Luc Defreyne, Prof MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Louvain Saint-Luc
name: Marc Van den Eynde, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maleux G, Monbaliu D, Verslype C, Casteleyn C, Van De Velde M, Cornillie P, Hoogeveen Y, Van Cutsem E. Percutaneous isolated liver perfusion with occlusion balloons and a catheter-based stent-graft-like perfusion device: an experimental study in a porcine model. Eur Radiol. 2010 Oct;20(10):2372-80. doi: 10.1007/s00330-010-1816-5. Epub 2010 May 22.
Clinical trial NCT05485558: the Safety and Efficacy of N-acetyl Cysteine in Children With Drug-Resistant Epilepsy
Official title: Clinical Study Evaluating the Safety and Efficacy of N-acetyl Cysteine in Children With Drug-Resistant Epilepsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Drug Resistant Epilepsy
Keywords: N-acetyl cysteine
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-08-03
Enrollment: 45
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims at investigating the possible efficacy and safety of N-acetyl cysteine as adjuvant therapy in the treatment of drug-resistant epilepsy

Detailed description: N-acetyl-cysteine (NAC), a glutathione precursor, is proven to activate the nuclear factor E2-related factor 2( Nrf2) in mouse models of status epilepticus, thus inhibiting high mobility group box 1 (HMGB1) cytoplasmic translocation in the hippocampal neural and glial cells and preventing the linkage between oxidative stress and neuroinflammation for which the redox-sensitive protein HMGB1 is central. Therefore,It may be useful as an adjuvant in treating various medical conditions, especially neuropsychiatry.

Eligibility criteria: Inclusion Criteria:

* Patients aged 3-18 years with intractable childhood-onset epilepsy.

  * All patients are diagnosed to have drug-resistant epilepsy (refractory epilepsy) according to the ILAE definition.
  * The subject is willing and able to comply with the study requirements

Exclusion Criteria:

* Any metabolic conditions that might increase the risks associated with trial participation or investigational product administration, such as hepatic enzyme elevation greater than twice normal and/or a GFR \< 60 mL/min/1.73 m2 or electrolyte imbalance.

  * Patients with Known allergy to N-acetyl cysteine.
  * Patients taking antioxidant and/or anti-inflammatory medications

Primary outcomes:
measure: effectivness of acetyl cysteine for controlling epileptic seizures in children with drug resistant epilepsy.
timeFrame: 6 months
Secondary outcomes:
measure: analyze the differences of improvement of quality of life via using Helth related quality of life questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
Study officials:
affiliation: Tanta University
name: Ahmed kishk, Lecturer
role: STUDY_DIRECTOR
References:
Clinical trial NCT05425758: Optimal Index for Pediatric Distal Forearm Fractures
Official title: What is the Optimal Index for Assessment of Plaster Cast Quality in Pediatric Distal Forearm Fractures
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pediatric Distal Forearm Fractures
Keywords: Optimal index for Pediatric distal forearm fractures
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children 3-12 years of age with displaced distal forearm fractures requiring manipulation for and will be treated with casting.

Brief summary: This is a prospective radiographic study of displaced distal forearm fractures requiring manipulation for children 3-12 years of age and will be treated with casting.The patients' full radiographic series (including the pre-manipulation, immediate post-manipulation, after 1 week and after 4 weeks radiographs) will be evaluated.


Eligibility criteria: Inclusion Criteria:

1. Males or females 3 to 12 years old.
2. Any presentation of displaced distal forearm fractures requiring manipulation and will be treated with casting.

Exclusion Criteria:

1. Children with compound fractures (those with unacceptable initial reduction, fracture dislocations, and fractures with physeal separation) will be excluded from the study, as those will be treated with Kirschner wires.
2. Children whose casts is split will be excluded.

Primary outcomes:
measure: The cast index
timeFrame: 4 weeks observation after reduction and applying cast.
measure: The gap index
timeFrame: 4 weeks observation after reduction and applying cast.
measure: The padding index
timeFrame: 4 weeks observation after reduction and applying cast.
measure: The Canterbury index
timeFrame: 4 weeks observation after reduction and applying cast.
measure: The three-point index
timeFrame: 4 weeks observation after reduction and applying cast.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01326858: Safety and Comfort of AL-4943A Ophthalmic Solution
Official title: A Randomized, Double-Masked, Crossover Study to Evaluate the Safety and Comfort of AL-4943A Ophthalmic Solution, 0.7%
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Allergic Conjunctivitis
Keywords: Ocular discomfort
AL-4943A Ophthalmic Solution
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2011-03-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to assess the ocular comfort and safety of olopatadine hydrochloride opthalmic solution. 0.7%.

Detailed description: In this 3-treatment, 3-period, 6-sequence crossover study, each subject will receive all 3 products in randomized order, 1 product at a time, with a washout period of 24 hours between treatment periods. Following instillation of study medication, subjects will complete a 3-minute discomfort profile.

Eligibility criteria: Inclusion Criteria:

* Able to be dosed in both eyes, to follow instructions, and willing and able to attend required study visits.
* Negative urine pregnancy test if female of childbearing potential and use adequate birth control throughout the study period.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* History or clinical evidence of ocular herpes simplex or ocular herpes zoster infectious disease.
* History of any clinically significant external ocular disease within 30 days of the start of the study.
* Presence of active blepharitis, active meibomian gland dysfunction, active rosacea affecting the ocular surface/lid margin, active or chronic follicular conjunctivitis, preauricular adenopathy, or any other ocular or periocular abnormality that may affect the study outcomes.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Peak discomfort score over a 3-minute period after drop instillation
timeFrame: Up to Day 3
Secondary outcomes:
measure: Ocular Symptoms
timeFrame: Up to Day 3
measure: Product Acceptability
timeFrame: Up to Day 3
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Abhijit Narvekar, MS, MBBS
role: STUDY_DIRECTOR
References:
Clinical trial NCT01338558: A Study of Avastin (Bevacizumab) in Combination With mFOLFOX6 in Treatment-Naïve Patients With Metastatic Colorectal Cancer With or Without K-RAS Mutations, and Comparison to Cetuximab
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-04-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, open-label study will evaluate the safety and efficacy of Avastin (Bevacizumab) added to standard mFOLFOX6 chemotherapy in treatment-naïve patients with Stage IV metastatic colorectal cancer. According to K-RAS gene mutation status, patients will be assigned or randomized to receive either Avastin 5 mg/kg intravenously (iv) on Day 1 of each 2-week cycle or cetuximab 400 mg/m2 iv on Day 1 followed by 250 mg/m2 iv every week, in addition to mFOLFOX6 every 2 weeks. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.


Eligibility criteria: Inclusion Criteria:

* Adult patients \>/= 18 years of age
* Histologically confirmed adenocarcinoma of the colon or rectum
* Stage IV metastatic disease with at least one measurable metastatic lesion according to RECIST criteria
* Tumour tissue sample available for assessment of K-RAS and BRAF genes
* Prior radiotherapy must have been completed 4 weeks before randomization
* Adequate bone marrow, kidney and liver function
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Exclusion Criteria:

* Previous chemotherapy for metastatic disease
* Completion of adjuvant treatment for colorectal cancer (Stage I, II and III) in the 12 months preceding randomization
* Prior treatment with bevacizumab, cetuximab or other EGFR inhibitors
* Clinical or radiographic evidence of brain metastases
* Clinically significant cardiovascular disease or disorder
* History of neoplastic disease other than colorectal cancer in the 3 years prior to start of study treatment, except for successfully treated non-invasive carcinomas such as cervical cancer in situ, basal cell carcinoma of the skin or superficial bladder tumours
* HIV, hepatitis B or C infection

Primary outcomes:
measure: Progression-free survival: native versus mutated K-RAS; tumour assessments according to RECIST criteria
timeFrame: up to 4 years
Secondary outcomes:
measure: Overall survival
timeFrame: up to 4 years
measure: Objective response rate
timeFrame: 4 years
measure: Safety: Incidence of adverse events
timeFrame: 4 years
measure: Quality of Life: European Organisation for Research and Treatment of Cancer Quality of Life questionnaire (EORTC QLQ-C30)
timeFrame: up to 4 years
measure: Progression-free survival: comparison of the two treatment regimens in the native K-RAS arms
timeFrame: up to 4 years
Other outcomes:
Locations:
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02050958: Pilot Study of OXP001 and Brufen in Healthy Subjects
Official title: A Randomised, Open Label, Evaluator Blinded, Multiple Dose, Parallel Arm, Phase I Pilot Study of OXP001 Ibuprofen 400 mg Tablets and Brufen 400 mg Tablets in Normal, Healthy, Adult, Human Subjects Under Fasting Conditions to Assess The Incidence of Upper Gastrointestinal Irritation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: NSAID Related Gastric Irritation
Lead sponsor: Oxford Pharmascience Ltd
Sponsor class: INDUSTRY
First posted: 2014-01-31
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Oxford Pharmascience (the sponsor) is developing a new formulation of Ibuprofen (OXP001 - the study drug) which it is proposed will have less of the side effects than are currently reported with standard prescription strength Ibuprofen.

This study will compare the study drug to an already marketed formulation of prescription strength Ibuprofen (the reference product) by looking at how the drug is taken up by the body and also by performing a specialist procedure called an endoscopy (or more specifically a gastroscopy). The safety and tolerability of the study drug will also be assessed.

The study will involve approximately 44 healthy male and female subjects. Subjects will be randomly assigned to receive either the study drug or reference product for 8 days. On Day 1, subjects will receive a single 800 mg dose of ibuprofen. On Days 2 to 9, subjects will receive 800 mg ibuprofen three times a day.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects
* Aged 18-55 years
* Normal, healthy upper gastrointestinal tract

Exclusion Criteria:

* History of or concurrent gastric irritation or ulcers
* History of allergy to non-steroidal anti-inflammatory drugs (NSAIDs)

Primary outcomes:
measure: Gastric irritation as measured by a Lanza score
timeFrame: 7 days
Secondary outcomes:
measure: Number of erosions
timeFrame: 7 days
measure: Number of ulcers
timeFrame: 7 days
measure: Incidence of gastric irritation
timeFrame: 7 days
measure: Lanza score in stomach and duodenum
timeFrame: 7 days
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Quotient Clinical
Study officials:
affiliation: Quotient Clinical Ltd
name: Stuart Mair, MB ChB
role: PRINCIPAL_INVESTIGATOR
References: