louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00287703: Pulsed Electro Magnetic Fields (PEMF) Treatment in Patients With Treatment-Resistant Major Depression in Ongoing Pharmacological Treatment of Depression
Official title: Pulsed Electro Magnetic Fields (PEMF) Treatment in Patients With Treatment-Resistant Major Depression in Ongoing Pharmacological Treatment of Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depression
Keywords: Major depression
Treatment resistant
PEMF
AQT
Hamilton
Lead sponsor: Hillerod Hospital, Denmark
Sponsor class: OTHER
Collaborators: name: The Lundbeckfoundation
name: Biofields
First posted: 2006-02-07
Enrollment: 50
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: About 30% of patients with major depression are treatment resistant to pharmacological treatment. In the search for new methods to treat depression a great interest has been put into the use of electromagnetic fields. This study tests the hypothesis that ultra-weak electromagnetic fields with a specific wave pattern (PEMF = pulsed electro magnetic fields) can alleviate the symptoms of depression.

Detailed description: In this study, a patient with treatment resistant depression, as defined by Harold Sackeim, is subjected to 5 weeks of treatment with active or sham PEMF treatment for 30 minutes on every working day. The pharmacological treatment for depression is maintained unaltered throughout the study. Depression severity is measured at the beginning of the study and at each weekly visit. Side effects are closely observed. The ability to concentrate is measured by the AQT test (Alzheimers Quick Test). Personality is assessed by use of the SCID-II-instrument (DSM-IV axis II).

Eligibility criteria: Inclusion Criteria:

* Major depression
* Treatment resistance
* Age above 18 years
* Hamilton 17 item score above 13
* Unaltered pharmacological treatment in last 4 weeks

Exclusion Criteria:

* Psychotic disorder
* Mental retardation
* Suicidality
* Earlier treatment with PEMF
* Abuse of alcohol or other substances
* Patient not able to come to appointed visits
* Antisocial, borderline or schizotypic personality disorder
* Women lactating or pregnant
* Unreliable contraception

Primary outcomes:
measure: Hamilton Depression Rating Scale score (depression)
timeFrame: 1 week
Secondary outcomes:
measure: AQT, measure of concentration
timeFrame: weekly
Other outcomes:
Locations:
city: Municipality of Frederiksberg
country: Denmark
facility: Speciallægerne Falkoner Allé
Study officials:
affiliation: Psychiatric Research Unit Fredericksburg General Hospital
name: Klaus Martiny, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martiny K, Lunde M, Bech P. Transcranial low voltage pulsed electromagnetic fields in patients with treatment-resistant depression. Biol Psychiatry. 2010 Jul 15;68(2):163-9. doi: 10.1016/j.biopsych.2010.02.017. Epub 2010 Apr 10.
Clinical trial NCT05201703: Fycompa in Catamenial Epilepsy
Official title: Pilot Study of Add-On Fycompa (Perampanel)Treatment for Catamenial Epilepsy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Catamenial Epilepsy
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Eisai Inc.
First posted: 2022-01-21
Enrollment: 7
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the proposed investigation is to carry out a pilot study of add-on perampanel (Fycompa) in women with perimenstural (C1) catamenial epilepsy. Perampanel, a noncompetitive AMPA receptor antagonist, is uniquely positioned to decrease progesterone receptor mediated excitotoxicity. This mechanism of action would allow a novel use of perampanel as an effective treatment of C1 catamenial epilepsy.


Eligibility criteria: Inclusion Criteria:

* Female
* Diagnosis of focal onset seizures (FOS) i. Established by clinical history and an EEG ii. Patients with a normal EEG may be included if they met other diagnostic criteria based on clinical history
* Presumably ovulatory women based on menstrual cycles of 21-35 days from beginning of menstrual flow to the beginning of the next menses
* ≥18-50 years old
* ≥2 unprovoked seizures per month despite drug trials with ≥1 first-line anti-epileptic drugs (AED)
* Seizures must show a C1 catamenial pattern in 2 of 3 documented cycles i. C1 pattern will be defined as a two-fold increase in average daily seizure frequency during the menstrual phase, as compared to the follicular and luteal phases of the ovulation cycle, in 2 of 3 documented cycles. The menstrual phase will be defined as days -3 to +3 of the menstrual cycle (where onset of menstruation is defined as day 1) (Herzog et al, 1997). Of note, in the NIH Progesterone Trial, the level of catameniality was 1.69 based on Herzog et al. (1997) criteria though this trial will use a level of 2 to include women only with high levels of perimenstrual catamenial exacerbation.
* Willingness and ability to comply with scheduled visits and study procedures

Exclusion Criteria:

* Progressive neurologic or systemic disorder
* Use of systemic hormonal contraception during 3 months prior to enrollment (however, subjects with a progestin-releasing IUD who still have monthly periods may be enrolled)

  a. Women on system hormonal contraception will be excluded as these women are not ovulatory
* Subject is pregnant or breastfeeding
* Active suicidal or homicidal ideation
* Comatose individuals.

Primary outcomes:
measure: Responder Rate (Percent of Patients Experiencing a 50% or Greater Reduction in Seizures) Relative to Baseline Seizure Frequencies
timeFrame: Baseline (2 months) and treatment (2 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Katherine Zarroli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04147403: A Study of Extended Total Mesopancreas Excision(eTME) for Pancreatic Head Adenocarcinoma.
Official title: Xinhua Hospital, Affiliated to Shanghai Jiao Tong University, School of Medicine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreas Adenocarcinoma
Keywords: pancreatic head adenocarcinoma; total mesopancreas excision;pancreaticoduodenectomy
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Ruijin Hospital
name: Shanghai Zhongshan Hospital
First posted: 2019-11-01
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with resectable pancreatic head adenocarcinoma who underwent radical resection between January 1st 2008 and October 31st 2018 in collaborated tertiary hospital hospitals.

Brief summary: The study of extended total mesopancreas excision(eTME) for pancreatic head adenocarcinoma is a retrospective multicenter cohort, collecting medical records and follow-up data of patients who underwent radical resection with pancreatic head adenocarcinoma.

Detailed description: The objectives of the study are as follows:

1. To evaluate the perioperative safety of extended total mesopancreas excision(eTME) for patients who diagnosed with resectable pancreatic head adenocarcinoma.
2. To demonstrate the prognosis of extended total mesopancreas excision(eTME) for patients who diagnosed with resectable pancreatic head adenocarcinoma.

Eligibility criteria: Inclusion Criteria:

1. Patients with pancreatic head adenocarcinoma who underwent curative-intent resection.
2. Patients with accessible medical records

Exclusion Criteria:

1. Patients with unknown chemotherapy sequence or status
2. Patients with history of previous malignant tumors
3. Patients with distant metastases

Primary outcomes:
measure: Overall survival
timeFrame: 5 years
Secondary outcomes:
measure: Disease free survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital,Affiliated to Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Changhai Hospital Affiliated to Naval Medical University
state: Shanghai
city: Shanghai
country: China
facility: Xinhua Hospital, Affiliated to Shanghai Jiao Tong University, School of Medicine
state: Shanghai
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Yingbin Liu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06441903: Connective Tissue of Pectoralis Major Muscle: Anatomical Study
Official title: Connective Tissue of Pectoralis Major Muscle: Anatomical Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tendon Injury - Upper Limb
Keywords: Anterior Deltoid Tendon
Anterior Lamina Pectoralis Major
Posterior Lamina Pectoralis Major
Pectoralis Major Tendon
Ultrasound
Deep Fascia Pectoralis Major
Delto Pectoral Tendon
Lead sponsor: CMC Ambroise Paré
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 46
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: Adults with no history of pectoralis major and consulting for a musculoskeletal pathology of the upper limb

Brief summary: The delto-pectoral tendon (DPT) is a new tendon recently identified. It completes the insertion of the pectoralis major and perfectly explains the different injuries encountered.

The objective of this observational study is to visualize this new tendon, the DPT, using ultrasound, to measure it, to characterize its role in the overall architecture of the pectoralis major muscle and to analyze its relationship with its main tendon and the anterior and posterior laminae.


Eligibility criteria: Inclusion Criteria:

* Patient \> 18 years,
* Consultation for a musculoskeletal pathology of the upper limb

Exclusion Criteria:

* History of pathology of the pectoralis major or of the distal tendon of the pectoralis major
* Pregnant or breastfeeding women
* Patient under protection of the adults (guardianship, curators or safeguard of justice)
* Unable to understand
* Opposition by the patient

Primary outcomes:
measure: Ultrasound visualization of Delto Pectoral Tendon
timeFrame: Day 1
Secondary outcomes:
measure: Measurement of DPT by ultrasonography (height, length and thickness in mm)
timeFrame: Day 1
measure: Measurement of ADT by ultrasonography (height, length and thickness in mm)
timeFrame: Day 1
measure: Measurement of PMT by ultrasonography (height, length and thickness in mm)
timeFrame: Day 1
measure: Measurement of the distances in mm between the PMT humeral insertion and the different connective structures: ADT, DPT, ALPM, PLPM and DFPM
timeFrame: Day 1
measure: Ultrasound visualization of the clavicular and sternal portions of the pectoralis major.
timeFrame: Day 1
Other outcomes:
Locations:
city: Neuilly-sur-Seine
country: France
facility: Ambroise Paré - Hartmann Private Hospital Group
state: Ile de France
Study officials:
References:
Clinical trial NCT04293003: Metabolic Effects of Morning 16/8 Fasting
Official title: Short-term Metabolic Effects of Morning Energy Restriction Versus Two Different Early-day Nutrition Strategies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2020-03-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: A study to address the effects of early-day fasting on fat tissue mobilization in comparison to a typical isocaloric Mediterranean and a low-carbohydrate breakfast.

Detailed description: The study design meets a cross-over pattern with 3 different morning visits of 6 hour duration each. After an informed consent is received from the participant, a crude medical history, physical examination and collection of somatometric data through bio-impendance analysis will take place. An intravenous catheter will be placed in the participants forearm.

At zero time point, depending on study visit, participants will either (A) remain fasted (B) start consuming ta pre-prepared zero-carbohydrate 500 kcal test meal (C) start consuming ta pre-prepared 500 kcal test meal with a composition conforming to a standard Mediterannean breakfast. Participants will be given 10 minutes to consume the meal.

Blood samples will be drawn and visual analogue scales (VAS) for hunger and satiety will be filled in at the following time points (min): -15, 0, 15, 30, 60, 90, 120, 180, 240, 300, 360.

Eligibility criteria: Inclusion Criteria:

* BMI 18-25 kg/m2
* Willfulness to participate

Exclusion Criteria:

* Overweight or obesity (BMI\>25 kg/m2)
* Type 1 or 2 diabetes mellitus
* Uncontrolled thyroid disorders

Primary outcomes:
measure: Mobilisation of adipose tissue
timeFrame: 6 hours
Secondary outcomes:
measure: Mobilisation of gut peptides
timeFrame: 6 hours
measure: Degree of appetite suppression
timeFrame: 6 hours
measure: Degree of satiety induction
timeFrame: 6 hours
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Diabetes Clinical Research Laboratory, 1st Department of Propaedeutic Internal Medicine
Study officials:
References:
Clinical trial NCT03347903: Prevalence and Clinical Characteristics of Patients With Jackhammer Esophagus and Symptoms of Gastroesophageal Reflux Disease
Official title: Prevalence and Clinical Characteristics of Patients With Jackhammer Esophagus and Symptoms of Gastroesophageal Reflux Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Motility Disorders
Keywords: esophagus
motility
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2017-11-20
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients that are referred to our center undergo esophageal high-resolution manometry and ambulatory pH monitoring for screening of gastroesophageal reflux disease and motility disorders. We assess the data that are prospectively obtained. Patients do not have to undergo any interventions.

Brief summary: Gastroesophageal reflux disease (GERD) is involved in the development of esophageal motility disorders like Jackhammer esophagus (JE), a novel hypercontractile condition that was associated with progression to achalasia and limited outcomes following surgical anti-reflux therapy.

This trial was designed to assess the prevalence and characteristics of JE in patients with typical symptoms of GERD and responsiveness to PPI therapy.

Detailed description: Jackhammer esophagus is a novel hypercontractile esophageal disorder. The investigators assess the prevalence and clinical characteristics of patients diagnosed with this disorder out of a collective of patients that are referred with symptoms of gastroesphageal reflux disease and respond to PPI. This is an observational trial.

Eligibility criteria: Inclusion Criteria:

* Patients with symptoms of gastroesophageal reflux disease and diagnosis of Jackhammer esophagus

Exclusion Criteria:

* patients not willing to participate data or undergo screening for gastroesophageal reflux disease

Primary outcomes:
measure: Prevalence of Jackhammer esophagus in patients referred with symptoms of gastroesophageal reflux disease
timeFrame: January 2014- May 2017
Secondary outcomes:
measure: Symptom perception
timeFrame: January 2014- May 2017
measure: Prevalence of gastroesophageal reflux disease in patients with Jackhammer esophagus
timeFrame: Januar 2014- May 2017
Other outcomes:
Locations:
Study officials:
affiliation: Vice Chair of Department of General Surgery
name: Sebastian Schoppmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kristo I, Schwameis K, Maschke S, Kainz A, Rieder E, Paireder M, Jomrich G, Schoppmann SF. Phenotypes of Jackhammer esophagus in patients with typical symptoms of gastroesophageal reflux disease responsive to proton pump inhibitors. Sci Rep. 2018 Jul 2;8(1):9949. doi: 10.1038/s41598-018-27756-9.
Clinical trial NCT03931603: Endometriosis of the Recto-sigmoid: MRI (Magnetic Resonance Imaging) Criteria Predictive of Shaving or Segmental Resection
Official title: Endometriosis of the Recto-sigmoid: MRI Criteria Predictive of Shaving or Segmental Resection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriotic Parietal Involvement of the Rectosigmoid
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-04-30
Enrollment: 61
Sex: FEMALE
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 treated in the gynecological surgery departments of the University Hospital Center of the Civil Hospitals of Lyon: Lyon Sud.

Brief summary: Evaluate MRI criteria predictive of the type of surgery to be performed for an "in sano" resection of endometriotic involvement of the recto-sigmoid by a resection without opening of the rectal mucosa ("shaving") versus a segmental resection.

Detailed description: PURPOSE: To retrospectively determine the accuracy of MRI rectal and pararectal signs in predicting a segmental resection of lesions located in the rectum until the recto-sigmoid junction.

MATERIALS AND METHODS: Institutional review board approval for this study was obtained and waived written informed consent. The MR images of 61 patients treated for rectal endometriosis over a 6 years period were reviewed. Two blinded readers performed in consensus a systematic analysis of 7 rectal (length, transverse axis, thickness and circumference of the lesion, and presence of a convex base, submucosal edema and hyperintense cystic areas) and 4 pararectal (posterior vaginal fornix, parametrial, ureteral and sacro-recto-genital septum involvements) signs for each lesion. MR imaging results were compared with surgical procedure (shaving versus segmental resection). Efficacy parameters were calculated with 95 % confidence intervals (CIs).

Eligibility criteria: Inclusion Criteria:

* operated patient for a pelvic endometriosis with resection without opening of the rectal mucosa ("shaving") or with segmental resection of the recto-sigmoidienne.
* Performing a preoperative pelvic MRI with at least 2 perpendicular T2 planes

Exclusion Criteria:

* Refusal to use clinical data and exploration acquired
* Absence of interpretable preoperative pelvic MRI

Primary outcomes:
measure: Comparison of MRI data with intraoperative data and anatomopathology
timeFrame: Intraoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre Benite
country: France
facility: Hospices Civils de Lyon - Centre Hospitalier Lyon Sud -Service de Radiologie
Study officials:
References:
Clinical trial NCT02540603: Evaluation of a Full Face Mask for the Treatment of Obstructive Sleep Apnea (OSA) in NZ
Official title: Evaluation of a Full Face Mask for the Treatment of Obstructive Sleep Apnea (OSA) in NZ
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2015-09-04
Enrollment: 15
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 investigation is designed to evaluate the performance (leak and comfort) as well as participant's overall acceptance of the investigative full face mask amongst OSA participants.

Detailed description: A total number of up to 15 OSA participants who currently use full face masks will be recruited for the trial. Participants will be on the trial for three weeks, using the prototypes at home for two weeks. PAP baseline data on the participant's prescribed treatment pressure with their usual mask and will be collected for one week prior to mask fitting with the full face trial mask.

Eligibility criteria: Inclusion Criteria:

* 18+ years of age
* Diagnosed with OSA by a practicing physician
* Prescribed PAP therapy (Bi-Level or Continuous Positive Airway Pressure (CPAP) or Automatic Positive Airway Pressure (APAP))
* Existing full face users

Exclusion Criteria:

* Inability to give informed consent
* Patients who are in a coma or decreased level of consciousness
* Anatomical or physiological conditions making PAP therapy inappropriate (e.g unconsolidated facial fracture)
* Commercial Drivers who are investigated by New Zealand Transport Agency (NZTA)
* Current diagnosis of CO2 retention
* Pregnant or think they may be pregnant

Primary outcomes:
measure: Number of participants with average system leak >60L/min
timeFrame: Two weeks in-home use
Secondary outcomes:
measure: Insights into mask fitting and removal.
timeFrame: Two weeks use
measure: Number of participants that found the mask comfortable.
timeFrame: Two weeks in-home use
Other outcomes:
Locations:
Study officials:
References: