louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02728622: Chemotherapy vs Hormonal Treatment in Platinum-resistant Ovarian Cancer Resistant or Refractory to Platinum and Taxane
Official title: A Randomized Study of Chemotherapy Versus Hormonal Treatment in Patients With Ovarian Cancer Resistant or Refractory to Platinum and Taxane
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ovarian Cancer
Peritoneal Cancer
Cancer of the Fallopian Tube
Keywords: ovarian cancer
platinum-resistant
endocrine treatment
chemotherapy
tamoxifen
Lead sponsor: Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Sponsor class: OTHER
First posted: 2016-04-05
Enrollment: 241
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized study of chemotherapy versus hormonal treatment in patients with ovarian cancer resistant or refractory to platinum and taxane.

Detailed description: Patients with platinum-resistant invasive epithelial ovarian, fallopian tube or peritoneal cancer will be randomized 1:2 to either hormonal treatment with Tamoxifen 40 mg daily or chemotherapy of investigator's choice (weekly paclitaxel given as an 1 hour infusion of paclitaxel 80 mg/m2 or pegylated liposomal doxorubicin 40 mg/m2 given every 4 weeks).

Eligibility criteria: Inclusion Criteria:

* Patients with invasive epithelial ovarian, fallopian tube or peritoneal cancer, being resistant to treatment with platinum and a taxane, either given in combination or sequentially.
* Patients with clinical progression during or within 6 months after end of treatment for primary disease or relapse.
* Patients with stable disease after 6 courses of chemotherapy for primary disease or relapse if further treatment is indicated.
* Patients with doubling of s-CA 125 to at least 70 IU/Ml within 3 months after end of treatment for primary disease or relapse.
* Age must be at least 18 years.
* Performance status must be 0-2 (WHO/ECOG, appendix 1).
* Informed consent given according to ICH/EU GCP guidelines and local or national laws

Exclusion Criteria:

* Patients with symptomatic brain metastasis
* Bilirubin greater than 2 x UNL (upper normal limits), white blood cell count below 3.0 x 109/L, neutrophil count below 1.5 x 109/L, platelets count below 100 x 109/L.
* Active infection or other serious underlying medical condition which might prevent the patient from receiving treatment or to be followed.
* Pregnant, lactating, or child bearing potential patients without adequate contraception
* Previous treatment with Tamoxifen.

Primary outcomes:
measure: Quality-adjusted survival
timeFrame: through completion of study, on average 1 year
Secondary outcomes:
measure: progression-free survival
timeFrame: through completion of study, on average 3 months
measure: overall survival
timeFrame: through completion of study, on average 1 year
Other outcomes:
Locations:
Study officials:
affiliation: The Norwegian Radium Hospital, Oslo University Hospital
name: Gunnar B Kristensen, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT03574922: The Effects of Core Stabilization Exercises in Addition to Balance Exercises in Adult Hemophilia Patients on Balance, Quality of Life, Lower Limb Muscle Strength and Functional Level
Official title: The Effects of Core Stabilization Exercises in Addition to Balance Exercises in Adult Hemophilia Patients on Balance, Quality of Life, Lower Limb Muscle Strength and Functional Level
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemophilia
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2018-07-02
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to investigate the effects of core stabilization exercises in addition to balance exercises on balance, quality of life, lower extremity muscle strength and functional level in adult hemophilic patients.

Detailed description: The aim of this study is to investigate the effects of core stabilization exercises in addition to balance exercises on balance, quality of life, lower extremity muscle strength and functional level in adult hemophilic patients.

Eligibility criteria: Inclusion Criteria:

* Hemophilia Patients

Exclusion Criteria:

* Acute Bleeding

Primary outcomes:
measure: Balance Tests
timeFrame: 8 Weeks
Secondary outcomes:
measure: Functionality Tests
timeFrame: 8 Weeks
Other outcomes:
Locations:
city: Aydın
country: Turkey
facility: Sercan Aykar
Study officials:
affiliation: Hacettepe University
name: Filiz Can
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00704522: Adherence in Patients Receiving PegIntron Pen/Rebetol for Hepatitis C in Conjunction With a Patient Assistance Program (Study P04281)(COMPLETED)
Official title: Evaluation of Adherence Rate in Patients Receiving PegIntron Pen / Rebetol for Hepatitis C in Conjunction With a Patient Assistance Program.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Hepacivirus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-06-25
Enrollment: 601
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: Adult patients receiving a patient assistance program during therapy for hepatitis C at sites in Austria.

Brief summary: Patients receiving a patient assistance program during therapy for Hepatitis C will be enrolled into this study. All patients will receive PegIntron pen and Rebetol according to label and the patient assistance program. This study will be compared to similar studies from other clinics using various patient support programs for the purpose of designing future comparative phase IV studies.


Eligibility criteria: Inclusion Criteria:

* Adult patients with hepatitis C

Exclusion Criteria:

* According to the products' labeling (refer to Warnings, contraindications, and safety sections).

Primary outcomes:
measure: Number of Participants Who Complete Treatment With PegIntron Pen/Rebetol Therapy for Hepatitis C When Administered With a Patient Assistance Program
timeFrame: 24 or 48 weeks (depending on genotype) and 24 weeks of follow up
measure: Average Length of Treatment With PegIntron/Rebetol
timeFrame: After start of treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05297422: Axillary Approach to Brachial Plexus Blockade Using Ketamine, Regional Versus Intravenous Administration
Official title: Administration of Ketamine to Branchial Plexus Block Using Axillary Approach : Comparative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Branchial Plexus Blockade
Anesthesia
Keywords: Axillary Approach
Ketamine
Adjuvant
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2022-03-28
Enrollment: 81
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to assess Ketamine as an adjuvant to Branchial Plexus Blockade.

Detailed description: After being informed about the study, patients giving written informed consent will undergo anaesthesia using the Ultrasound Guided Axillary Approach to Brachial Plexus Blockade, in order to undergo forearm surgery. The purpose of this study is to assess whether Ketamine as an adjuvant lengthens sensory and motor blockade and whether it has an effect on "rebound pain" when the anaesthetic effect fades. Therefore the study will compare intravenous, regional and no administration of Ketamine as an adjuvant to Branchial Plexus Blockade. Patients will be asked to fill in a Pain VAS (Visual Analog Scale) for 24 hours following the intervention, in order to assess effectiveness of each anaesthetic method. Side effects, onset time, motor blockade score and rescue dose are also recorded.

Eligibility criteria: Inclusion Criteria:

* BMI 20-35
* ASA score I, II, III

Exclusion Criteria:

* Mental disorder
* Peripheral neuropathy
* Severe hepatic or renal disease
* Gastrointestinal bleeding history

Primary outcomes:
measure: VAS (Visual Analog Scale) over 24 hours following intervention
timeFrame: 24 hours
Secondary outcomes:
measure: Side Effects
timeFrame: 24 hours
measure: Motor Blockade Score
timeFrame: 24 hours
measure: Anesthesia Onset time
timeFrame: 24 hours
measure: Rescue Dose
timeFrame: 24 hours
Other outcomes:
Locations:
city: Athens
country: Greece
facility: National and Kapodistrian University of Athens
state: Attiki
Study officials:
affiliation: National Kapodistrian University of Athens
name: Theodoros Xanthos, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03707522: Growth Mindset Psychoeducation for Modifiable Risk Factors for CMD
Official title: The Effect of Growth Mindset Psychoeducation on Modifiable Risk Factors for Common Mental Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Anxiety
Lead sponsor: University of Nevada, Reno
Sponsor class: OTHER
First posted: 2018-10-16
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The present study aims to determine the effect of presenting psychoeducation emphasizing "growth-mindset," and information on modifiable risk factors (e.g., social contact, physical activity) on engagement with modifiable risk factors. The investigators hypothesize that psychoeducation emphasizing that mental health is malleable will increase the participant's engagement with risk factors outlined in the intervention.


Eligibility criteria: Inclusion Criteria:

* College freshmen

Exclusion Criteria:

* Not fluent in English

Primary outcomes:
measure: Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer & Williams, 2001)
timeFrame: 3 months
measure: Generalized Anxiety Disorder-7 (GAD-7; Spitzer, Kroenke, Williams & Lowe, 2006)
timeFrame: 3 months
Secondary outcomes:
measure: Cognitive and Behavioral Avoidance Scale (CBAS, Ottenbreit & Dobson, 2003)
timeFrame: 3 months
measure: Substance Use Measure (Lee et al., 2015)
timeFrame: 3 months
measure: Positive Reframing; Brief COPE (B-COPE; Carver, 1997)
timeFrame: 3 months
Other outcomes:
Locations:
city: Reno
country: United States
facility: University of Nevada, Reno
state: Nevada
Study officials:
affiliation: University of Nevada, Reno
name: Anthony Papa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carver CS. You want to measure coping but your protocol's too long: consider the brief COPE. Int J Behav Med. 1997;4(1):92-100. doi: 10.1207/s15327558ijbm0401_6.
citation: Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
citation: Lee JP, Lee RM, Hu AW, Kim OM. Ethnic Identity as a Moderator against Discrimination for Transracially and Transnationally Adopted Korean American Adolescents. Asian Am J Psychol. 2015 Jun;6(2):154-163. doi: 10.1037/a0038360.
citation: Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
citation: Zazpe I, Bes-Rastrollo M, Ruiz-Canela M, Sanchez-Villegas A, Serrano-Martinez M, Martinez-Gonzalez MA. A brief assessment of eating habits and weight gain in a Mediterranean cohort. Br J Nutr. 2011 Mar;105(5):765-75. doi: 10.1017/S0007114510004149. Epub 2010 Dec 8.
citation: Ottenbreit ND, Dobson KS. Avoidance and depression: the construction of the cognitive-behavioral avoidance scale. Behav Res Ther. 2004 Mar;42(3):293-313. doi: 10.1016/S0005-7967(03)00140-2.
Clinical trial NCT06226922: Risk Factors for Postoperative Nausea and Vomiting in Surgical Patients Undergoing Patient-controlled Intravenous Analgesia.
Official title: Risk Factors for Postoperative Nausea and Vomiting in Surgical Patients Undergoing Patient-controlled Intravenous Analgesia.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nausea and Vomiting, Postoperative
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2024-01-26
Enrollment: 1371
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent surgery at Peking Union Medical College Hospital from July 1, 2023 to October 31, 2023 and received patient-controlled intravenous analgesia after surgery

Brief summary: The purpose of this study is to identify the risk factors for postoperative nausea and vomiting (PONV) in surgical patients undergoing patient-controlled intravenous analgesia (PCIA).

Detailed description: Our study was a retrospective study, including patients who underwent surgery at Peking Union Medical College Hospital from July 1, 2023 to October 31, 2023 and underwent PCIA. Patient characteristics, past medical history, surgical information, intraoperative medication information, postoperative analgesia follow-up information were obtained through the electronic medical record system. The patients were divided into PCIA-PONV group and non-PCIA-PONV group depending on the occurrence of nausea and vomiting during PCIA, and all patients was also divided into PCIA-POV group and non-PCIA-POV according to whether vomiting occurred. Multivariate logistic regression analysis was used to identify the risk factors for PCIA-PONV and PCIA-POV.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Hospitalized patients
* Undergoing general anesthesia during surgery

Exclusion Criteria:

* Day surgery patients
* Accepting PCIA for less than 24 hours
* Medical record information is missing or unavailable.

Primary outcomes:
measure: PCIA-PONV
timeFrame: During the PCIA procedure after surgery
Secondary outcomes:
measure: PCIA-POV
timeFrame: During the PCIA procedure after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Shen Le, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04665622: Assessment of Empathetic Process by Scanpath Study of an Artwork
Official title: Theory of Mind, Empathy and Eye Gaze Strategies During an Artwork Observation in Neurodegenerative Pathologies.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Dementia
Parkinson Disease
Fronto-Temporal Dementia
Keywords: Eye-Tracking
Empathy
Social cognition
Theory of Mind
Scanpath
Gaze
Lead sponsor: Centre Hospitalier Princesse Grace
Sponsor class: OTHER
Collaborators: name: Association de Recherche Bibliographique pour les Neurosciences
First posted: 2020-12-11
Enrollment: 70
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A monocentric prospective, descriptive, comparative study.
Primary purpose: OTHER

Brief summary: Analysis of gaze patterns during social cognition tasks and standardised exploration of a specific artwork, between elderly subjects without cognitive disorders and subjects with neurodegenerative diseases such as Fronto-Temporal Dementia, Alzheimer's Dementia or Parkinson's Disease


Eligibility criteria: Inclusion Criteria:

* Male or Female.
* 60 years old and above.
* Sufficient written and oral expression in French.
* Benefit from French or Monaco Social security.
* Written informed consent signed by the patient.
* For the control group: voluntary subjects, without cognitive impairment.
* For the FTD / AD / PD groups: patients diagnosed with one of these diseases, and volunteers to participate in the study.

Exclusion Criteria:

* General anaesthesia within 3 months.
* Ophthalmological problems preventing a video-oculography examination.
* Oculomotor disorders such as "fixation disorders" or "ocular tracking disorders".
* History of stroke.
* Cognitive disorders of the type: visual agnosia, visuo-spatial disorder, visuo-perceptual disorder or aphasia.

Primary outcomes:
measure: 1. Gaze patterns
timeFrame: baseline
measure: 2.Gaze Patterns
timeFrame: Baseline
measure: 3.Gaze Patterns
timeFrame: Baseline
Secondary outcomes:
measure: Cognitive Theory of mind during an artwork observation: Score 1
timeFrame: Baseline
measure: Cognitive Theory of mind during an artwork observation: Score 2
timeFrame: Baseline
measure: Cognitive Theory of mind: TOM-15 a false-belief task to assess cognitive theory of mind
timeFrame: Baseline
measure: Affective ToM (Score 3)
timeFrame: Baseline
measure: Affective ToM : The Reading the Mind in the Eye test - RME - (Baron-Cohen S at al., 2001)
timeFrame: Baseline
measure: Affective empathy: Score 4.
timeFrame: Baseline
measure: Affective empathy: The Empathy Quotient (EQ).
timeFrame: Baseline
Other outcomes:
Locations:
city: Monaco
country: Monaco
facility: Centre Hospitalier Princesse Grace
Study officials:
References:
Clinical trial NCT00743522: Programming Implantable Cardioverter Defibrillators in Patients With Primary Prevention Indication
Official title: Programming Implantable Cardioverter Defibrillators (ICDs) in Patients With Primary Prevention Indication to Prolong Time to First Shock
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shock
Keywords: Reducing shocks
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2008-08-29
Enrollment: 1670
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: Patients with approved ICD/CRT-D indications

Brief summary: Although shock therapy is effective in terminating ventricular tachycardia (VT), it can be painful to the patient and repetitive shocks can decrease a patient's quality of life. Previous studies have suggested that one or more sets of aggressive device parameter settings may reduce the total number of shocks in primary prevention patients. In addition to shock therapies, antitachycardia pacing (ATP) is also available in ICDs to treat VT. The PROVIDE trial aims to prospectively study the effect of high detection rates, prolonged detection intervals, aggressive SVT discriminators, and extensive ATP therapy in prolonging the time to first shock in primary prevention patients.


Eligibility criteria: Inclusion Criteria:

* Primary Prevention indication for ICD/ CRT-D

Exclusion Criteria:

* No prior documented history of spontaneous VT/VF

Primary outcomes:
measure: The primary endpoint of this study is the rate of first shock
timeFrame: Average follow-up period is 530 days
measure: The primary safety endpoint of this study is the rate of arrhythmic syncope
timeFrame: Average follow-up period is 530 days
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Hall-Garcia Cardiology Associates
state: Texas
Study officials:
affiliation: Hall-Garcia Cardiology Associates
name: Mohammad Saeed, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Saeed M, Hanna I, Robotis D, Styperek R, Polosajian L, Khan A, Alonso J, Nabutovsky Y, Neason C. Programming implantable cardioverter-defibrillators in patients with primary prevention indication to prolong time to first shock: results from the PROVIDE study. J Cardiovasc Electrophysiol. 2014 Jan;25(1):52-9. doi: 10.1111/jce.12273. Epub 2013 Sep 24.
citation: Sanders P, Connolly AT, Nabutovsky Y, Fischer A, Saeed M. Increased Hospitalizations and Overall Healthcare Utilization in Patients Receiving Implantable Cardioverter-Defibrillator Shocks Compared With Antitachycardia Pacing. JACC Clin Electrophysiol. 2018 Feb;4(2):243-253. doi: 10.1016/j.jacep.2017.09.004. Epub 2017 Nov 15.
Clinical trial NCT01793922: POEM Trial: Multi-center Study Comparing Endoscopic Pneumodilation and Per Oral Endoscopic Myotomy (POEM)
Official title: A Prospective Randomized Multi-center Study Comparing Endoscopic Pneumodilation and Per Oral Endoscopic Myotomy (POEM) as Treatment of Idiopathic Achalasia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Achalasia
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2013-02-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare the efficacy of per-oral endoscopic myotomy (POEM) to the efficacy of pneumodilation as the initial treatment of symptomatic idiopathic achalasia. It is hypothesized that POEM has a higher long-term efficacy than pneumodilation in treatment of therapy-naive patients with idiopathic achalasia.


Eligibility criteria: Inclusion Criteria:

* Between 18 and 75 yr of age
* Manometric diagnosis of achalasia
* Eckardt score \> 3
* Informed consent

Exclusion Criteria:

* Severe cardio-pulmonary disease or other serious disease leading to unacceptable surgical risk previous treatment, except treatment with nitroderivatives, Ca++ channel blockers or sildenafil, or dilation with Savary bougies or balloons of 2 cm diameter or smaller.

Pseudo-achalasia Mega-esophagus (\> 7 cm) and/or sigmoid-like esophagus Previous esophageal or gastric surgery (except for gastric perforation) Not capable to fill out questionnaires (f.e. due to language barrier) Not available for follow-up Esophageal diverticula in the distal esophagus Malignant or premalignant esophageal lesions Patients with liver cirrhosis and/or esophageal varices Pregnancy

Primary outcomes:
measure: therapeutic succes
timeFrame: 2 years
Secondary outcomes:
measure: quality of life
timeFrame: 2 years
measure: complication rate
timeFrame: 2 years
measure: need for retreetment
timeFrame: 2 years
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
References: