louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01284153: Potential Benefits of Radiotherapy in Prone Position for Breast Cancer Patients: a Planning Study
Official title: A Comparison of Three Radiotherapy Techniques for Breast Cancer: a Planning Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Neoplasms
Radiation
Keywords: respiratory gating
prone radiotherapy
breast cancer
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2011-01-26
Enrollment: 30
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have an indication for radiotherapy of the breast and/or the lymph nodes.

Brief summary: This study has the purpose to investigate the benefit of treating breast cancer patients in prone position. This treatment is compared to the standard technique in our center (supine position with or without respiratory gating). The investigators want to compare the doses on the organs at risk (heart and lungs) in the different techniques.


Eligibility criteria: Inclusion Criteria:

* indication for radiotherapy of the breast and /or lymph nodes

Exclusion Criteria:

* none ( planning study)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven Radiotherapy Department
Study officials:
affiliation: UZ Leuven
name: Caroline Sweldens, Doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02088853: Diet Induced Intestinal Mucosal Adaptation
Official title: Small Intestinal Adaptation to Isocaloric Diets Dominated Either by Fats or Carbohydrates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Conditions
Keywords: intestinal
metabolic control
mucosa
human
diet
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Sahlgrenska University Hospital
First posted: 2014-03-17
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Human beings are 'omnivores' meaning that all principal components of food (i.e. the macronutrients: carbohydrates, fat, proteins) can be assimilated by the gastrointestinal tract. When the gut mucosa is exposed to dietary changes it adjusts its functional behaviour. For example, a fatty diet demands certain digestive mechanisms, whereas others are needed to take care of a carbohydrate rich diet. Such dietary induced changes in appearance and functionality of the small intestinal mucosa have been described in animals but only little is known about it in man. The present project aims at elucidating in man if a 2 weeks diet dominated by either fat or carbohydrates, but with similar energy content, is associated with changes in the small intestinal mucosal appearance and metabolic signalling capacity.


Eligibility criteria: Inclusion Criteria:

healthy volunteer not taking prescribed medications BMI ≤25 kg/m2

Exclusion Criteria:

BMI ≥26 kg/m2 smoker previous or current gastrointestinal disease significant abdominal surgery pregnancy/breast feeding drug intolerance of importance (particularly opiates and midazolam used during endoscopy) history of drug addiction

Primary outcomes:
measure: Mucosal surface enlargement factor
timeFrame: Appearance after 2 weeks of diet
Secondary outcomes:
measure: Epithelial electrical current in-vitro
timeFrame: The condition after 2 weeks diet
measure: Mucosal electrical resistance in vitro
timeFrame: The condition after 2 weeks diet
measure: Glycemic control following a test meal
timeFrame: The condition after 2 weeks diet
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Dept of Gastrosurgical R&E, Sahlgrenska Universityhospital
Study officials:
affiliation: Göteborg University
name: Lars Fändriks, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Elebring E, Wallenius V, Casselbrant A, Docherty NG, Roux CWL, Marschall HU, Fandriks L. A Fatty Diet Induces a Jejunal Ketogenesis Which Inhibits Local SGLT1-Based Glucose Transport via an Acetylation Mechanism-Results from a Randomized Cross-Over Study between Iso-Caloric High-Fat versus High-Carbohydrate Diets in Healthy Volunteers. Nutrients. 2022 May 7;14(9):1961. doi: 10.3390/nu14091961.
Clinical trial NCT06645353: Evaluation of Perfusion and Oxygenation in Muscle of Patients With PAD Undergoing LER
Official title: Evaluation of Perfusion and Oxygenation in Muscle of Patients With PAD Undergoing LER
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Peripheral Arterial Disease
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
Collaborators: name: iThera Medical GmbH
First posted: 2024-10-16
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: • Participants with PAD stage 4 - 6 (Rutherford) with indication for interventional LER

Brief summary: During this IIT, the MSOT (Multispectral Optoacoustic Tomography ) Acuity Echo will be used to scan participants with Peripheral Arterial Disease assess MSOT Multispectral Optoacoustic Tomography (single-wavelength and hemoglobin-related parameters) in the Tibialis Anterior, and flexor hallucis brevis, at multiple time-points before, during and after interventional Lower Extremity Revascularization (LER ).

Primary aim of the study ist the Comparison of the difference between oxygenated, deoxygenated hemoglobin and oxygenation in the tibialis anterior, and flexor hallucis brevis, at multiple time-points before, during and after interventional Lower Extremity Revascularization.


Eligibility criteria: Inclusion Criteria:

* • Written consent of the participant after being informed

  * Adults above 18 years
  * Participants with PAD stage 4 - 6 (Rutherford) with indication for interventional LER

Exclusion Criteria:

* • Participants with previous LER on the same leg

  * Participants less than 18years
  * Pregnancy
  * Participants with tattoos in the scan area
  * Participants with no clinical indication for interventional LER
  * Missing consent form

Primary outcomes:
measure: MSOT Multispectral Optoacoustic Tomography,
timeFrame: baseline pre LER, 30 minutes post LER, 24 hours post LER, 48hours post LER
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01431053: Study of Aspirin and Exemestane as Adjuvant Treatment in Breast Cancer
Official title: Phase 2 Study of Aspirin Plus Exemestane Comparing With Exemestane Alone in the Adjuvant Treatment of Postmenopausal Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Neoplasms
Keywords: exemestane
aspirin
quality of life
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2011-09-09
Enrollment: 160
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a phase II study to assess efficacy/safety of Exemestane with or without Aspirin as the adjuvant treatment in postmenopausal breast cancer patients.


Eligibility criteria: Inclusion Criteria:

* Breast cancer after surgery postmenopausal

Exclusion Criteria:

* contraindication of aspirin

Primary outcomes:
measure: Quality of Life
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Peng Yuan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02230553: Lapatinib Plus Trametinib in KRAS Mutant NSCLC
Official title: Phase I/II Study With Lapatinib Plus Trametinib in Patients With Metastatic KRAS Mutant Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Colorectal Cancer
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2014-09-03
Enrollment: 30
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: This is an open-label phase I/II multi-center study consisting of two parts. Part A of this study is designed to identify the recommended phase 2 dose (RP2D) of lapatinib combined with trametinib in patients with metastatic KRASm and PIK3CA wild-type (PIK3CAwt) non-small cell lung cancer (NSCLC). Part B is designed to perform a randomized comparison of the lapatinib-trametinib combination versus standard of care therapy in patients with metastatic KRASm/PIK3CAwt NSCLC.


Eligibility criteria: Inclusion Criteria:

* Histological or cytological proof of metastatic NSCLC; for PART B: treated with first line therapy for metastatic disease only.
* Written documentation of a known pathogenic KRAS (exon 2, 3 or 4) mutation and PIK3CA wild-type (exon 9 and 20)
* Age ≥ 18 years
* Able and willing to give written informed consent
* WHO performance status of 0 or 1 (part A and B)

Exclusion Criteria:

* Any treatment with investigational drugs within 30 days prior to receiving the first dose of investigational treatment.
* History of another primary malignancy
* Symptomatic or untreated leptomeningeal disease
* Symptomatic brain metastasis
* History of interstitial lung disease or pneumonitis
* Uncontrolled infectious disease or known Human Immunodeficiency Virus HIV-1 or HIV-2 type patients
* Retinal degenerative disease (hereditary retinal degeneration or age-related macular degeneration), or a history of uveitis, retinal vein occlusion, central serous retinopathy, or retinal detachment
* Patients with left ventricular ejection fraction (LVEF) \< 50%

Primary outcomes:
measure: Incidence rate of dose-limiting toxicities
timeFrame: 1.5 years
measure: progression free survival
timeFrame: 2.5 years
measure: overall response rate
timeFrame: 2.5 years
Secondary outcomes:
measure: Incidence and severity of adveres events
timeFrame: 2.5 years
measure: Plasma concentration
timeFrame: 2.5 years
measure: Duration of response
timeFrame: 2.5 years
measure: Time to response
timeFrame: 2.5 years
measure: Overall survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: The Netherlands Cancer Institute
Study officials:
affiliation: The Netherlands Cancer Institute
name: F Opdam, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05679453: Lornoxicam Versus Etodolac After Third Molar Surgery
Official title: Comparison of Lornoxicam and Etodolac on Edema, Trismus and Pain After Third Molar Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Acute
Edema
Trismus
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2023-01-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: Our study aimed to compare the effect of lornoxicam and etodolac on postoperative pain, edema and trismus following lower third molar extraction

Detailed description: 20 patients included in study (4 male, 16 female). Lornoxicam and etodolac was given following lower third molar extraction. Pain was evaluated 2., 6., 12., 24., and 48. hours using VAS. Edema was evaluated by measuring tragus-labial commissure, angulus- lateral canthus of eye and angulus mandible-labial commissure. Trismus was evaluated measuring mouth opening by caliper. Edema and Trismus was evaluated by 48. and 168. hours

Eligibility criteria: Inclusion Criteria:

* Bilateral mesioangular impacted lower third molar
* Asymptomatic Third Molar (No history of infection)
* Systemically Healthy Person
* Person Between aged 18-30

Exclusion Criteria:

* People who are pregnant and lactation process
* People who had any systemic disease
* People who are gastrointestinal problems
* People who are sensitive to drugs used in study
* Lower Third Molar associated with cysts and infections

Primary outcomes:
measure: Pain after wisdom tooth extraction
timeFrame: 2 th hours
measure: Edema after wisdom tooth extraction
timeFrame: 48 th hours
measure: Trismus after wisdom tooth extraction
timeFrame: 48 th hours,
Secondary outcomes:
measure: Pain after wisdom tooth extraction
timeFrame: 6 th hours
measure: Pain after wisdom tooth extraction
timeFrame: 12 th hours
measure: Pain after wisdom tooth extraction
timeFrame: 24 th hours
measure: Pain after wisdom tooth extraction
timeFrame: 48 th hours
measure: Edema after wisdom tooth extraction
timeFrame: 168 th hours
measure: Trismus after wisdom tooth extraction
timeFrame: 168 th hours
Other outcomes:
Locations:
city: Kutahya
country: Turkey
facility: Zülfikar Karabıyık
Study officials:
References:
Clinical trial NCT01285453: Safety and Tolerability of ASA404 Administered in Combination With Docetaxel in Japanese Patients With Solid Tumors
Official title: A Safety, Tolerability Study of Intravenous ASA404 Administered in Combination With Docetaxel in Japanese Patients With Advanced or Recurrent Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced or Recurrent Solid Tumors
Keywords: ASA404,
vadimezan,
docetaxel
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-01-28
Enrollment: 9
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess the tolerability of combination therapy with ASA404 and docetaxel in Japanese patients with advanced or recurrent solid tumors.


Eligibility criteria: Inclusion Criteria:

1. Patients with confirmed solid tumors whose disease has progressed or recurred after treatment at lease one therapy, except docetaxel
2. WHO Performance Status of 0-1

Exclusion Criteria:

1. Patients having symptomatic CNS tumor/metastasis and requiring treatment
2. Patients who have received prior therapy with ASA404 or other vascular disrupting agents
3. Patients with systolic BP \> 160mmHg and/or diastolic BP \> 90mmHg
4. Patients with fluid retention
5. Patients with any one of cardiotoxicities
6. Concomitant use of drugs with a risk of prolonging the QT interval
7. Known allergy or hypersensitivity to taxane or polysorbate 80

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Daga H, Hida T, Ishikawa S, Shimizu J, Tokunaga S, Horio Y, Kobayashi K, Takeda K. The safety and tolerability of intravenous ASA404 when administered in combination with docetaxel (60 or 75 mg/m(2)) in Japanese patients with advanced or recurrent solid tumors. Jpn J Clin Oncol. 2011 Sep;41(9):1067-73. doi: 10.1093/jjco/hyr110. Epub 2011 Aug 10.
Clinical trial NCT03461653: Telemedicin Counselling for Medical Abortion
Official title: Efficacy of Medical Abortion Through Telemedicine Versus Standard Provision - a Randomised Controlled Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medical Abortion Counselling
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2018-03-12
Enrollment: 1598
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised trial
Primary purpose: OTHER

Brief summary: The guidance on Safe abortion technology by the World Health Organization (WHO 2012) suggests the evaluation of internet provision and telemedicine, as further alternative service delivery channels of safe abortion, as a subject for future research (WHO 2012) Our studies have shown that telemedicine and provision of medical abortion through wow is safe, acceptable and with outcomes similar to medical abortion provided traditionally following face-to-face counselling. Furthermore, recently home self-assessment of the abortion outcome through a low sensitivity U-hCg test was shown to be highly acceptable to women. To evaluate whether counselling through telemedicine is non-inferior to face-to face counselling a RCT will be conducted including women who chose medical abortion up to 63 days of gestation with home administration of misoprostol and self assessment of the outcome. The results of this study could be of major importance to increase access to safe and acceptable abortion services.


Eligibility criteria: Inclusion Criteria:

* requesting termination of pregnancy by means of mifepristone followed by home administration of misoprostol at \< /=63 days of gestation, no contraindication to medical abortion and self administration of misoprostol at home, and who have given their informed consent

Exclusion Criteria:

* women who do not want home administration of misoprostol, women who are unable to communicate in Swedish, or English, and women with symptoms and signs of ectopic pregnancy.

Primary outcomes:
measure: Proportion of women with complete abortion
timeFrame: 30 days of abortion treatment
Secondary outcomes:
measure: Rate of reported complications that require additional treatment.
timeFrame: 30 days
measure: Proportions of women who would chose the same mode of provision in case of a future medical abortion
timeFrame: 30 days
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
References:
Clinical trial NCT00327353: Influence Of Different Airflow Resistances On Drug Effect Of 50μg Salmeterol And 6 μg Formoterol
Official title: Single-Centre Randomised Open Crossover Study to Examine the Influence of Different Internal Resistances of Discus and Turbohaler Respectively on the Effects of Salmeterol and Formoterol in Asthmatic Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: Asthma
Salmeterol
Formoterol
Airway resistance
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-05-18
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Effect of inhaled drugs administered as dry powder is not only dependent on drug efficacy but also on technical properties of the inhalers. Different inhalers have different internal resistances and therefore it is expected that patients with limited airflow may have different exposure rates of drugs delivered from different devices


Eligibility criteria: Inclusion criteria:

* Asthma Reversibility \>15% and 200 ml in total FEV1 \<85% of normal

Exclusion criteria:

* Smoking history \>20 pack years Treatment with ICS \>500μg Fluticasone or aquivalent in the last 4 weeks Asthma exacerbation in the last 4 weeks

Primary outcomes:
measure: Forced expiratory volume in 1 second (FEV1) under time curve 0.5-6 hours after inhalation of study medication
Secondary outcomes:
measure: Airway resistances and peak FEV1 measured 0.5, 1, 2, 4 and 6 hours after inhalation of study drug
Other outcomes:
Locations:
city: Gauting
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Berlin
country: Germany
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00332553: Study of Hot Flashes and Night Sweats in Postmenopausal Women Receiving Combination Raloxifene and Oral Estrogen
Official title: Study of Vasomotor Symptoms in Postmenopausal Women Receiving Combination Raloxifene and Oral Estrogen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vasomotor Symptoms
Endometrial Safety
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2006-06-01
Enrollment: 150
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This pilot study was designed to explore the effects of combined treatment with raloxifene HCl 60 mg and oral 17 beta-estradiol 1mg/day on the number of vasomotor episodes (hot flashes plus night sweats) in postmenopausal women discontinuing continuous combined hormone replacement therapy (ccHRT) compared to women treated with raloxifene HCl 60 mg alone.


Eligibility criteria: Inclusion Criteria:

* Post menopausal women, 50-70 years of age
* Had taken ccHRT for at least 6 months prior to study entry
* No unexplained vaginal bleeding in the 3 months prior to study entry
* Understand and sign an informed consent document

Exclusion Criteria:

* Prior hysterectomy
* Endometrial thickness (excluding endometrial fluid) greater than 8 mm or endometrial fluid greater than or equal to 4 mm at study entry
* Abnormal Pap smear at study screening or within the preceding 3 years
* Abnormal transvaginal ultrasound result at study screening
* Past or current history of malignant neoplasms

Primary outcomes:
measure: Compare the number of vasomotor symptoms at 12 weeks between those women taking the combination of raloxifene with oral estradiol versus those taking raloxifene alone.
Secondary outcomes:
measure: Determine the effect of treatment with combined raloxifene and estradiol compared with raloxifene alone on the severity of vasomotor symptoms as well as on the frequency and severity of hot flashes and night sweats
measure: Determine the effects of treatment with combined raloxifene and estradiol in postmenopausal women on endometrial and general safety
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877- CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician.
state: Indiana
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5PM Eastern time (UTC/GMT-5 hours, EST)
role: STUDY_DIRECTOR
References: