louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01227304: SMOOCH - Small Volume Challenges to Predict Volume Responsiveness: Prospective Interventional Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prediction of Volume Responsiveness
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2010-10-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: * test for volume responsiveness
* PiCCO-guided infusion over a pre-defined period of time


Eligibility criteria: Inclusion Criteria:

* Patients are equipped with PiCCO monitoring independently to the study.
* One criteria of decreased usefulness of the parameters of preload/volume responsiveness available using the PiCCO device:

  1. Femoral access of the central venous catheter precluding application of the normal ranges of global enddiastolic volume index and central venous pressure.
  2. Absence of sinus rhythm and/or controlled ventilation precluding the use of stroke volume variation.
  3. Evidence of increased intraabdominal pressure which is known to further reduce the usefulness of central venous pressure.
  4. Contradictory suggestions by stroke volume variation and global enddiastolic volume index.
  5. Intolerance of passive leg raising.
  6. Absence of therapeutic alternatives to volume resuscitation.

Exclusion Criteria:

* Extravascular volume-over plus: global enddiastolic volume index \> 1000ml/sqm
* Pulmonary edema: extravascular lungwater index \> 20ml/kg
* Cardiogenic shock without volume deficiency (cardiac index \<2L/min; global enddiastolic volume index \> 850ml/sqm)

Primary outcomes:
measure: Prediction of volume responsiveness defined as an increase in Cardiac Index of ≥ 15% after transpulmonary thermodilution measurement of 15 minutes
timeFrame: 15 minutes after start of infusion
measure: Prediction of volume responsiveness defined as an increase in Cardiac Index of ≥ 15% after transpulmonary thermodilution measurement of 30 minutes
timeFrame: 30 minutes after start of infusion
Secondary outcomes:
measure: Predictive capabilities of Cardiac Index (measured by pulse contour)
timeFrame: within 30 minutes after start of infusion
measure: Comparison of global enddiastolic volume index to baseline values
timeFrame: 30 minutes after start of infusion
measure: Comparison of central venous pressure levels to baseline values
timeFrame: 30 minutes after start of infusion
Other outcomes:
Locations:
city: Munich
country: Germany
facility: 2nd Medical Department, Klinikum rechts der Isar
Study officials:
References:
Clinical trial NCT02224404: Post Market Clinical Follow-up Investigation to Evaluate Performance and Safety on Pressure Ulcers, PU, When Using Exufiber as Intended
Official title: Open, Non-comparative, Multi-centre Post Market Clinical Follow-up Investigation to Evaluate Performance and Safety on Pressure Ulcers, PU, When Using Exufiber as Intended
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Ulcers
Lead sponsor: Molnlycke Health Care AB
Sponsor class: INDUSTRY
First posted: 2014-08-25
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this post market clinical follow-up (PMCF) investigation is to evaluate performance and safety of Exufiber when used as intended in Stage II-IV pressure ulcers (PU).


Eligibility criteria: Inclusion Criteria:

1. Both gender ≥18 years old.
2. Subjects with Stage 2, 3 or 4 cavity pressure ulcer (acc to EPUAP)
3. Exuding pressure ulcer
4. Signed Informed Consent.

Exclusion Criteria:

1. Known allergy/hypersensitivity to the dressing.
2. Infected wounds, (2 signs of infection/local inflammation and a positive swab)
3. Stage 1 PU
4. Dry wounds
5. Subjects who will have problems following the protocol
6. Subjects included in other ongoing clinical investigation at present or during the past 30 days

Primary outcomes:
measure: Number of Participants With Worsening in Peri-Skin Wound.(Maceration From Baseline to 6 Weeks)
timeFrame: 6 weeks
Secondary outcomes:
measure: Evaluate the Level of Pain at Week 6 Changes in Wound Status, Clinician's and Subject's Opinion, and Technical Performance
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Dep. of Plastic Surgery UZ Bruzzel
city: Gent
country: Belgium
facility: University Hospital Gent, Belgium
city: Kortrijk
country: Belgium
facility: Dermatologie Campus Kennedylaan
city: Helsinki
country: Finland
facility: Töölö Hospital
Study officials:
affiliation: University Hospital Gent, Belgium
name: Hilde Beele, prof. dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03900104: Cervical and Endometrial Injection for Sentinel Lymph Node Detection in Endometrial Cancer
Official title: Cervical and Endometrial Injection for Sentinel Lymph Node Detection in Endometrial Cancer: A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Cancer
Sentinel Lymph Node
Keywords: Endometrial Cancer
Sentinel Lymph Node
Paraaortic nodes involvement
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2019-04-02
Enrollment: 81
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The investigators think that trans-cervical endometrial tracer injection will cause more paraaortic sentinel lymph node detection. Also, this application is easy, cost-effective and safer than hysteroscopic method. Transtubal tumor spearing will not occur with this method.

Detailed description: Endometrial tracer injection will be performed by cervical or transcervical endometrial methods. Pelvic and para-aortic sentinel lymph node detection capacity will be assessed in this study.

Eligibility criteria: Inclusion Criteria:

* Endometrial Cancer Patients
* Suitable patients for surgical staging

Exclusion Criteria:

* Patients who cannot undergo cervical or transcervical endometrial injection
* Pathology did not confirm endometrial cancer
* Sarcoma of the uterine corpus
* If a 90-day follow-up was not feasible

Primary outcomes:
measure: Detected pelvic and paraaortic sentinel lymph node numbers
timeFrame: Postoperative 30 days
Secondary outcomes:
measure: Numbers adverse events
timeFrame: Postoperative 90 days
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University
Study officials:
affiliation: Kocaeli University
name: Şener Gezer, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Solima E, Martinelli F, Ditto A, Maccauro M, Carcangiu M, Mariani L, Kusamura S, Fontanelli R, Grijuela B, Raspagliesi F. Diagnostic accuracy of sentinel node in endometrial cancer by using hysteroscopic injection of radiolabeled tracer. Gynecol Oncol. 2012 Sep;126(3):419-23. doi: 10.1016/j.ygyno.2012.05.025. Epub 2012 May 30.
citation: Niikura H, Kaiho-Sakuma M, Tokunaga H, Toyoshima M, Utsunomiya H, Nagase S, Takano T, Watanabe M, Ito K, Yaegashi N. Tracer injection sites and combinations for sentinel lymph node detection in patients with endometrial cancer. Gynecol Oncol. 2013 Nov;131(2):299-303. doi: 10.1016/j.ygyno.2013.08.018. Epub 2013 Aug 27.
Clinical trial NCT02515604: Comparison of Single and Repeated Dose of Vaginal Misoprostol for the Treatment of Early Pregnancy Failure
Official title: Comparison of Single and Repeated Dose of Vaginal Misoprostol for the Treatment of Early Pregnancy Failure - a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Abortion, Missed
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2015-08-05
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomised controlled trial assessing the efficacy of single versus repeated dose of vaginal misoprostol for the treatment of early pregnancy failure.


Eligibility criteria: Inclusion Criteria:

* Women with early pregnancy failure, defined as missed abortion or blighted ovum, seeking medical treatment with misoprostol.
* Age equal or greater than 18 years
* Gestational age less than 12 complete weeks.

Exclusion Criteria:

* Complete, incomplete, inevitable, or septic abortion.
* Hemodynamically unstable patients.
* Misoprostol sensitivity or contraindication.
* Multifetal pregnancies.

Primary outcomes:
measure: Complete abortion (Endometrial thickness of less than 15 mm, as assessed by trans-vaginal ultrasound.)
timeFrame: Day 8 from first misoprostol dose
Secondary outcomes:
Other outcomes:
Locations:
city: Holon
country: Israel
facility: Wolfson Medical Center
Study officials:
affiliation: Wolfson Medical Center
name: Yossi Mizrachi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mizrachi Y, Dekalo A, Gluck O, Miremberg H, Dafna L, Feldstein O, Weiner E, Bar J, Sagiv R. Single versus repeat doses of misoprostol for treatment of early pregnancy loss-a randomized clinical trial. Hum Reprod. 2017 Jun 1;32(6):1202-1207. doi: 10.1093/humrep/dex074.
Clinical trial NCT02579304: Diagnostic Value of Transbronchial Lung Cryobiopsy
Official title: Feasibility, Safety and Diagnostic Value of Transbronchial Lung Cryobiopsy in the Work-up of Diffuse Interstitial Lung Diseases.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Interstitial Lung Disease
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2015-10-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: interstitial lung disease, fibrotic or non-fibrotic

Brief summary: Evaluating the diagnostic value of transbronchial lung cryobiopsy (TBLC) as well as its procedural feasibility and safety in a prospective series of 20 patients with diffuse interstitial lung diseases (DILD) who are referred for invasive histopathological diagnostics

Detailed description: Before one is able to state that TBLC is a technique that is an alternative for VATS biopsy, the diagnostic value of TBLC should be assessed and the value of the histopathological sampling should be compared with what is achieved by surgical lung biopsy. For this purpose direct comparison between VATS biopsy and TBLC is unavoidable. By including TBLC in the work-up of patients with DILD in which histopathological assessment is indicated (as proposed by MDD), we want to assess 3 major points of concern.

Agreement for the histopathological diagnosis between VATS biopsy and TBLC. Value of TBLC in the specific diagnosis in ILD.

Eligibility criteria: Inclusion Criteria:

* - Case of DILD presented at the MDD
* Referral for VATS biopsy as advised by MDD.
* Informed consent available
* Age \> 18
* FVC \> 50%pred
* DLCO \> 40%pred
* PaO2 \> 65 mmHg, pCO2 \< 45 mmHg
* No exclusion criteria

Exclusion Criteria:

* - Age \> 75
* PAPS \>40mmHg as measured on transthoracic cardiac ultrasound
* Platelet count \<100000/µl
* INR \> 1.4
* BMI \>30
* Diffuse bullous lung disease
* Active anti-platelet or anticoagulant treatment
* Active heart failure or unstable coronary heart disease
* Patients unfit for VATS under general anaesthesia as assessed by the surgeon and/or anesthesiologist

Primary outcomes:
measure: histopathological agreement
timeFrame: 2 years
Secondary outcomes:
measure: procedural safety : bleeding
timeFrame: periprocedural 1 hour
measure: procedural safety : bleeding (2)
timeFrame: periprocedural 1 hour
measure: procedural safety : bleeding (3)
timeFrame: periprocedural 1 hour
measure: procedural safety : penumothorax
timeFrame: periprocedural 1 hour
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: jonas Yserbyt
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01116804: Role PET Imaging in Response Assessment for Hepatocellular Carcinoma (HCC)
Official title: Role PET Imaging in Response Assessment for Hepatocellular Carcinoma (HCC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Primary Liver Cancer
Keywords: Primary liver cancer
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: University Ghent
First posted: 2010-05-05
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Present imaging modalities for primary liver cancer (hepatocellular carcinoma or HCC) have several shortcomings. One important shortcoming is the time delay between successful treatment and radiological confirmation of this response. Often it takes several months for anatomical changes to occur and to be appreciated on morphological imaging such as CT or MRI (shrinkage of tumor, absence of contrast enhancement). Functional imaging by means of Fluor-18 deoxyglucose or Fluor-18 Choline (positron emitters, PET-scan) might be an early indicator of response. This "early" information might help to tailor treatment. For instance, if no response is induced, an early switch in therapy can be planned.

The present study investigates whether the routine PET-tracer (Fluor-18 deoxyglucose) and the experimental PET-tracer, Fluor-18 Choline help to predict response if a patient with inoperable primary liver cancer is treated (radionuclide therapy, biologicals).


Eligibility criteria: Inclusion Criteria :

* Male and female are eligible

  -\>18years of age.No upper age limit.
* not pregnant or breastfeeding
* capable of understanding the study goals and protocol and to sign the informed consent.
* Patients are diagnosed with primary liver cancer and referred for treatment with biologicals such as Sorafenib or treatment with radionuclides.

Primary outcomes:
measure: To evaluate the efficacy of PET-imaging versus classic response assessment (MRI, CT-scam) in patients with inoperable liver cancer
timeFrame: 6 months after start of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Bieke Lambert, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01710904: A Non-interventional, Observational Study for Targinact® Treatment in Patients With Chronic Severe Pain
Official title: The Evaluation of Targinact® in Daily Practice, With Regards to Pain Relief and Constipation, in Chronic Severe Pain Patients Compared to Previous Prolonged Release Oxycodone Treatment: a Non-interventional, Observational Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Severe Pain
Keywords: Chronic pain
Severe pain
Oxycodone
Naloxone
Opioid-induced constipation
Opioid
Quality of life
Laxative
Analgesic rescue medication
Lead sponsor: Mundipharma CVA
Sponsor class: OTHER
First posted: 2012-10-19
Enrollment: 68
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: Primary and Secondary Care

Brief summary: This non-interventional, observational study is set up on request of the Belgian reimbursement authorities and evaluates the efficacy of Targinact with regard to pain relief and constipation in daily clinical practice in Belgium compared to the previous analgesic treatment with prolonged release oxycodone. Only patients eligible for Targinact® reimbursement in Belgium are included.

Detailed description: Patients are treated with Targinact® according to daily clinical practice during at least 12 weeks and are monitored during study 3 visits. Parameters assessed are pain relief, constipation, use of laxatives, use of analgesic rescue medication, use of concomitant medication, quality of life and safety of Targinact® treatment. These parameters, except for safety assessment, are compared between Targinact® treatment and previous analgesic treatment with prolonged release oxycodone.

Eligibility criteria: Inclusion criteria: patients included are patients who

* are eligible for Targinact® treatment according to the Targinact® SPC AND
* who have previously been treated with PR oxycodone during at least the last 30 days before study inclusion AND
* who are constipated (BFI \> 30) AND
* have used at least 2 laxatives with different modes of action during the previous PR oxycodone treatment

Exclusion criteria are based on Targinact® SPC.

Primary outcomes:
measure: Percentage of responders after Targinact treatment compared to the previous treatment with prolonged release oxycodone.
timeFrame: 12 weeks
Secondary outcomes:
measure: To assess laxative use during Targinact® treatment compared to previous PR oxycodone treatment (by physician)
timeFrame: 12 weeks
measure: To assess the use of analgesic rescue medication during Targinact® treatment compared to previous PR oxycodone treatment (by physician)
timeFrame: 12 weeks
measure: To evaluate the quality of life (EQ-5D questionnaire) during Targinact® treatment compared to previous PR oxycodone treatment (by patient)
timeFrame: 12 weeks
measure: To assess safety of Targinact® treatment (by physician)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: University Hospital Brussels
Study officials:
References:
Clinical trial NCT01278004: Chemotherapy Induced Painful Peripheral Neuropathy Ethosuximide (The CIN-E Study)
Official title: A Randomised Double-blind Placebo-controlled Trial of the Safety and Efficacy of Ethosuximide 250mg Capsules for the Management of Chemotherapy Induced Painful Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer
Peripheral Neuropathy
Keywords: Adult cancer patients with chemotherapy-induced painful peripheral neuropathy
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Imperial College London
First posted: 2011-01-17
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is a drug trial of ethosuximide as a painkiller if you develop pain as a side effect of chemotherapy. Ethosuximide will be compared against placebo (an inactive substance) to test whether any response is a true effect of the drug, and not a 'placebo effect'.


Eligibility criteria: Inclusion Criteria:

* Age \>/= 18
* Diagnosis of cancer
* Willing and able to give informed consent to the CIN-E study and complete study questionnaires, this involves adequate understanding of written and spoken English (translators will not be used)
* Chemotherapy-induced painful peripheral neuropathy as diagnosed by score of \>12 on the Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) with a pain intensity rating of \>4, on a 11 point numeric rating scale (0= no pain, 10= worst possible pain).
* Duration of chemotherapy-induced painful peripheral neuropathy \>4 weeks. Participant may either have completed chemotherapy, or be receiving ongoing chemotherapy.
* Able to attend research centre according to the required visit schedule.
* Diet allows bovine gelatine (present in both ethosuximide and placebo capsules)
* Women of child-bearing potential must be using a reliable form of contraception i.e. oral contraceptives, a barrier method (condom or diaphragm), intra-uterine device or abstinence.

Exclusion Criteria:

* Renal impairment (serum creatinine \>1.5x normal level)
* Deranged liver function (AST\>3x normal level)
* Patients currently taking any anti-depressant medication, for example fluoxetine, paroxetine, citalopram, venlafaxine, amitriptyline, or within the past week.
* Patients currently taking any other anti-epileptic drug, including gabapentin, or within the past week.
* Pregnancy
* Allergy to succinimides, ethosuximide, methsuximide, phensuximide. Pre-exisitng painful peripheral neuropathy of any other cause.

Primary outcomes:
measure: Reduction in pain intensity from baseline to endpoint as assessed on a Numerical Pain Rating scale.
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust
state: Surrey
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
Study officials:
References:
Clinical trial NCT02562404: Vagus Nerve Injury Post Radiofrequency Catheter Ablation for Atrial Fibrillation
Official title: Vagus Nerve Injury Post Radiofrequency Catheter Ablation for Atrial Fibrillation (Vagus Nerve Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Gastrointestinal Tract
Radiofrequency Catheter Ablation
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
First posted: 2015-09-29
Enrollment: 100
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: Atrial fibrillation patients at the Intermountain Medical Center Heart Rhythm Clinic who are candidates for Radiofrequency Catheter Ablation (RFCA) will be screened for participation in this study.

Brief summary: This study is an observational study designed to determine the extent of gastrointestinal (GI) post-procedure complications after Radiofrequency Catheter Ablation (RFCA) for atrial fibrillation (AF). This exploratory study will evaluate patient symptoms prior to the RFCA procedure, at 1 month post RFCA procedure, and at 3 months post RFCA procedure, through the administration of a questionnaire. The purpose of this study is to determine if vagus nerve injury resulting from RFCA for AF increases the risk of post-procedure GI complications that may present as temporary or permanent symptoms.


Eligibility criteria: Inclusion Criteria:

* Patients with a verified medical history of atrial fibrillation.
* Male or female \>18 years of age.
* Patients scheduled for an RFCA procedure, subsequent to failure of one Antiarrhythmic Drug (AAD class I, III or IV), or ablation.
* Ability to answer questions posed by the questionnaire.
* Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures.

Exclusion Criteria:

* None

Primary outcomes:
measure: Symptoms Associated with Vagus Nerve Injury
timeFrame: At RFCA procedure, 1 month post RFCA procedure, 3 months post RFCA procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
Study officials:
affiliation: Intermountain Medical Center
name: T. Jared Bunch, MD
role: PRINCIPAL_INVESTIGATOR
References: