louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01162941: Efficacy of Helicobacter Pylori Eradication, Anti-D and Danazol Combination in Steroid Dependant or Refractory Immune Thrombocytopenia (ITP)
Official title: Efficacy of Helicobacter Pylori Eradication, Anti-D and Danazol Combination in Steroid Dependant or Refractory Immune Thrombocytopenia (ITP)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Thrombocytopenia
Keywords: ITP
Lead sponsor: Cooperative Study Group A for Hematology
Sponsor class: NETWORK
First posted: 2010-07-15
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Proportion who would avoid splenectomy at 6 months of follow up

Detailed description: 1. If urea breath test (+); omeprazole 20mg bid, amoxicillin 1000mg bid and clarithromycin 500mg bid for 1 week.

   Second line Helicobacter pylori eradication will be permitted after failure of first line treatment.
2. Anti-D Anti-Ro 50 μg/kg IV for 2 days (D1, 2)
3. Danazol maintenance (from D1): Danazol will be continued at least 3 months. The dose of danazol can be reduced according to the adverse effects, especially in premenopausal women.

Eligibility criteria: Inclusion Criteria:

* 1.ITP is defined by

  * (a) a true thrombocytopenia on blood smear, (b) adequate megakaryopoiesis on bone marrow examination, (c) the absence of clinically apparent associated conditions or cause of thrombocytopenia
* 2.Steroid dependant ITP: more than 10 mg of prednisolone per day is required to maintain a platelet count above 20X109/L (minimum follow up duration: 3 months after diagnosis)
* 3.Steroid refractory ITP: a platelet count less than 20X109/L despite of treatment with full dose of steroid (prednisolone 1mg/kg for at least 4 weeks)
* 4.18 years old or more

Exclusion Criteria:

* 1.Patients who have a cause of thrombocytopenia such as HIV infection, lymphoproliferative disease, liver disease, definite SLE or drug
* 2.Pregnancy
* 3.Splectomized patients
* 4.Rh- blood type
* 5.Hemoglobin \< 10g/dL
* 6.Known hypersensitivity to immunoglobulins
* 7.A positive direct antiglobulin test
* 8.Clinically relevant hepatic or renal disease

Primary outcomes:
measure: Proportion who would avoid splenectomy at 6 months of follow up
timeFrame: 2years
Secondary outcomes:
measure: SR,IR
timeFrame: 2years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Asanbyeongwon-gil, songpa-gu
Study officials:
affiliation: Asan Medical Center
name: Jung-Hee Lee, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01464541: Orbital Fractures Measurement: Intraoperative Versus Computed Tomography (CT) Scan
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Orbital Fractures
Keywords: Orbit
Fracture
measurement
CT
intraoperative
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2011-11-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Purpose to compare the orbital fracture size measured by orbital CT scan and compare it to the actual orbital fracture size intraoperatively in patients who needed surgical intervention to correct the fracture.

Hypothesis: there is difference between the CT measure fracture size and the actual intraoperative size.


Eligibility criteria: Inclusion Criteria:

* With orbital fracture (trauma) proved by CT scan and need operative repair.
* Agree to participate.

Exclusion Criteria:

* Patients that refuse to be included in the study.
* Under the age of 18 years.
* CT not performed or not available.
* Not qualified to sign the consent form.

Primary outcomes:
measure: Patients with orbital fractures that require surgical repair will have their fracture"s" size measured intraoperatively by a ruler and/or a caliper in millimeters and compare it to the size measured by the CT scan.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: HaEmek medical center
state: North
city: Afula
country: Israel
facility: HaEme Medical center, Dept of Ophthalmology
Study officials:
affiliation: Chairperson, dept. of ophthalmology, haemek medical center, afula 18101, Israel
name: Daniel Briscoe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Resident, ophthalmology dept, Haemek Medical Center, Afula 18101, Israel
name: Wasseem Hilo, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06815341: Risk Factors for Sub Mucosal Fibrosis During Achalasia Cardia: A Prospective Study
Official title: Risk Factors for Sub Mucosal Fibrosis During Achalasia Cardia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Esophagus Disorder
Lead sponsor: Asian Institute of Gastroenterology, India
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 339
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 339 subjects

Brief summary: Classification for Stasis Esophagitis:

Grade I Grade II Grade III Vascular pattern Obscured Obscured Obscured Mucosal thickening No Yes Yes Ulceration No Yes Yes Nodularity No No Yes

Detailed description: Predictors of Submucosal Fibrosis:

Various factors were analysed for prediction of SMF including age, gender, stasis esophagitis, type of achalasia, duration of disease, lower esophageal sphincter pressure (LESP), height of barium column on barium esophagogram and severity of symptoms (Eckardt score). Esophageal mucosa was graded for the severity of stasis esophagitis (grade I to grade III) based on vascular pattern, mucosal thickening, ulceration and nodularity. SMF was graded (I minimal, II moderate, III severe) according to mucosal lift, difficulty in entry, density of SM fibers, separation of mucosa and muscle.

Eligibility criteria: Inclusion Criteria:

* Patients (between 18 to 75 years of age) who underwent POEM for achalasia or other esophageal motility disorders.
* Had a diagnosis of esophageal achalasia confirmed by High Resolution Manometry, barium esophagogram.

Exclusion Criteria:

* Patients who underwent treatment other than achalasia
* Lost to follow up patients.
* Incomplete clinical record patients
* Patients not willing to participate in the study

Primary outcomes:
measure: The primary aim of the study is to evaluate the predictors for Sub mucosal fibrosis in cases with achalasia cardia.
timeFrame: 100 minutes
Secondary outcomes:
measure: : To improve the technical outcomes of per oral endoscopy myotomy
timeFrame: 100 minutes
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Asian institute of Gastroenterology/AIG Hospitals
state: Telangana
city: Hyderabad
country: India
facility: Asian Institute of Gastroenterology /Aig Hospitals
state: Telangana
Study officials:
affiliation: AIG Hospitals
name: Zaheer Nabi Dr Mohammed, MBBS MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02869841: Efficacy of Rectal Sheath Analgesia After Midline Laparotomy
Official title: Efficacy of Rectal Sheath Analgesia After Midline Laparotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Surgery
Pain Postoperative
Keywords: laparotomy
pain
rectus sheath block
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
Collaborators: name: Admescope Ltd
First posted: 2016-08-17
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Midline laparotomy is commonly used in emergency and elective cancer surgery and patients need effective and safe pain treatment after this type of surgery. Nowadays modern anticoagulant therapy may prevent use of central regional blocks in pain management. Therefore in the present study the efficacy and safety of rectus sheath analgesia is studied using different administration techniques. The primary aim is the efficacy of the rectus sheath analgesia measured with pain ratings and the amount rescue opioid used.

Secondary aims were concentrations of local anesthetic, rescue opioid and satisfaction to analgesia method used.


Eligibility criteria: Inclusion Criteria: • Body mass index over BMI \<35 kg / m2

* not pregnancy/adequate contraception
* no contraindications to the local anaesthetic No contraindications to opioid patient controlled analgesia
* Informed consent obtained

Exclusion Criteria:

* • BMI \>35 kg / m2

  * Pregnant or breast feeding
  * Contraindication to local anaesthetics
  * Contraindication to opioids
  * Not able to use patient controlled analgesia pump
  * Relaparotomy
  * No informed consent

Primary outcomes:
measure: Amount of rescue analgesic used for pain relief
timeFrame: Time 0 h up to 48 h postoperatively
Secondary outcomes:
measure: Maximum levobupivacaine plasma concentration
timeFrame: Time 0 h to 48 h postoperatively
measure: maximum rescue analgesic concentration
timeFrame: time 0 h to 48 h postoperatively
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
state: Northern Savo
Study officials:
affiliation: Kuopio University Hospital
name: Matti Eskelinen, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT00663741: Sorafenib Gastric Cancer Asian Phase I Study
Official title: Phase I Study to Investigate Safety, Pharmacokinetics and Preliminary Efficacy Profile of Sorafenib (BAY 43-9006) in Combination With S-1 Plus CDDP in Asian Patients With Unresectable / Recurrent Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gastric Cancer
Keywords: Unresectable / recurrent gastric cancer
Sorafenib
S-1
Gastric
Cisplatin
CDDP
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-04-22
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to investigate safety, pharmacokinetics and preliminary efficacy profile of sorafenib in combination with S-1 plus cisplatin in Asian patients with unresectable / recurrent gastric cancer.


Eligibility criteria: Inclusion Criteria:

* Histological or cytological confirmation of the primary unresectable or recurrent gastric cancer (both with and without measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) are allowed). Peritoneal dissemination without ascites is allowed.
* No prior systemic anticancer therapy including chemotherapy, immunotherapy, targeted agents or experimental therapies for advanced disease
* Prior adjuvant therapy/neo adjuvant therapy is allowed if recurrence occurred 6 months after completion of these therapies
* Age \>/= 18 years and \< 75 years

Exclusion Criteria:

* Known brain metastasis, spinal cord compression or meningeal carcinomatosis.
* Clinically relevant ascites
* Concurrent cancer that is distinct in primary site or histology from gastric cancer
* Any condition that impairs patient's ability to swallow whole pills

Primary outcomes:
measure: Safety and pharmacokinetics
timeFrame: 20 weeks after start of treatment
Secondary outcomes:
measure: 1 year survival rate
timeFrame: 1 year after start of treatment
measure: Overall survival
timeFrame: 1 year after start of treatment
measure: Progression free survival
timeFrame: 1 year after start of treatment
measure: Response rate
timeFrame: 1 year after start of treatment
measure: Duration of response
timeFrame: Time from initial Response to documented Tumor Progression
Other outcomes:
Locations:
city: Kashiwa
country: Japan
state: Chiba
city: Kobe
country: Japan
state: Hyogo
city: Chuo-ku
country: Japan
state: Tokyo
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01100541: Evaluation of a Polymeric Plate Derived From Castor Oil to Thermotherapy
Official title: Evaluation of a Polymeric Plate Derived From Castor Oil to Thermotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Therapeutic Hyperthermia
Thermotherapy
Polymers
Keywords: Therapeutic Hyperthermia
Thermotherapy
Polymers
Castor Oil
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2010-04-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The objective of this work is to evaluate, from volunteers viewpoint, the usability, comfort, appearance, weight, superficial temperature, and other characteristics of a polymeric plate derived from castor oil developed to thermotherapy.

The volunteers will use polymeric plate as a therapeutic resource in the shoulder area and then fill in, without interference of the researcher, some questions about the characteristics of interest.

Detailed description: In this study, the polymeric plate is prepared using the following procedure:

1. - the water is heated to the boiling temperature
2. - the heater is shut down
3. - the polymeric plate is immersed in water
4. - it rests in the water for 15 minutes
5. - it is inserted in a wrap

In this condition, the polymeric plate is placed on the shoulder of the volunteer and remains there for 20 minutes.

After application, the volunteer answers the questionnaire containing eight questions on a Likert scale (0 to 10) and an area of observations.

Previous laboratory tests were performed to ensure that the temperature of the polymeric plate will not cause skin burn in this application condition.

Eligibility criteria: Inclusion Criteria:

* Good communication and comprehension
* Skin integrity

Exclusion Criteria:

* Reduced skin sensitivity
* Disturbance in the central nervous system

Primary outcomes:
measure: Acceptance of the polymeric plate
timeFrame: 2 weeks
Secondary outcomes:
measure: Polymeric plate comfort
timeFrame: 2 weeks
measure: Polymeric plate temperature
timeFrame: 2 weeks
measure: Polymeric plate time of heat retention
timeFrame: 2 weeks
measure: Sensation on the superficial touch of the polymeric plate
timeFrame: 2 weeks
measure: Appearance of the polymeric plate
timeFrame: 2 weeks
measure: Polymeric plate weight
timeFrame: 2 weeks
measure: Polymeric plate practicality
timeFrame: 2 weeks
measure: General observations about the polymeric plate
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Sao Carlos
country: Brazil
facility: Interunits postgraduate program in bioengineering
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Fabiula BM dos Santos, Physio
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Valéria MC Elui, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04869241: Changes in Muscle Activation When Carrying Backpacks
Official title: Changes in Muscle Activation of Serratus Anterior, Deltoid (Anterior) and Trapezius (Upper and Lower) According to the Methods of Carrying Backpacks
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Shoulder Muscle Activation
Surface Emg
Keywords: backpack
shoulder muscle activation
surface emg
deltoid, serratus anterior, trapezius
Lead sponsor: Bundang CHA Hospital
Sponsor class: OTHER
First posted: 2021-05-03
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To investigate change of shoulder muscles by measuring muscle activity according to the position of the backpack.

Detailed description: Most of modern people, including students and office workers, wear backpacks for a considerable amount of time. There have been prior studies on the change in muscle activity around the spine and shoulders muscles according to the weight of the backpack, but studies on the change in muscle activity according to the direction of the bag are insufficient. So this study is to evaluate the effect on the musculoskeletal system by comparing the activity of the muscles around the shoulder according to the anterior or posterior wearing of the backpack.

Muscles around the shoulder are composed of: Serratus anterior, trapezius(upper and lower) which control scapular movement and deltoid muscles which activate shoulder abduction directly. We would like to focus change of these muscles's activities when carrying a backpack according to the anterior or posterior direction and bilateral or unilateral.

To measure muscle activity, eight-channel electromyography (EMG) Using Nicolet EDX (Natus Medical Inc., San Carolos, CA, USA), surface EMG (sEMG) signal were used.

Eligibility criteria: Inclusion Criteria:

* Healthy adults from 20s to 50s

Exclusion Criteria:

* Restriction of joint motion range of shoulder and elbow
* Hisory of upper limb surgery in the past 6 months
* If there is an external wire such as a temporary external pacemaker or central line guide wire

Primary outcomes:
measure: Root mean square of each muscle activation
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Bundang CHA Medical Center
state: Gyeonggi-do
Study officials:
affiliation: Department of Rehabilitation Medicine, CHA Bundang Medical Center, CHA University School of Medicine
name: Kyunghoon Min, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01989741: Effect of Sleep Restriction on Decision Making and Inflammation
Official title: Effect of Sleep Restriction on Decision Making and Inflammation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Deprivation
Keywords: sleep restriction, decision making, wakefullness
Lead sponsor: Institut de Recherche Biomedicale des Armees
Sponsor class: OTHER_GOV
First posted: 2013-11-21
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: * hypothesis: sleep restriction in healthy subject trigger alteration of decision making associated with immuno-inflammatory changes
* inclusion criterias: healthy subjects, men, under 35 years, BMI\<26, no sleep troubles, intermediate chronotype
* design: 12 subjects, longitudinal study 2 days of baseline, 7 night of sleep restriction (4h sleep/night), recovery (1, 2, 3 and 9 normal sleep nights).
* parameters: decision making tests, reaction time, wakefulness test, biological parameters (cathecholamines, pro-inflammatory cytokines...), heart rate, blood pressure
* control of sleep restriction: continuous polysomnographic survey


Eligibility criteria: Inclusion Criteria:

* healthy men, \< 35 yr old, BMI\<26, intermediate chronotype

Exclusion Criteria:

* sleep trouble, acute or chronique disease (cardiological, neurological...), women

Primary outcomes:
measure: London tower test score (décision making)
timeFrame: up to 3 days
Secondary outcomes:
measure: wakefulness
timeFrame: maintenance of wakefulness test (MWT) score observed every day during baselline, sleep restriction and recovery at 09 AM, 12 AM, 4 PM and 7 PM
measure: cognitive function
timeFrame: up to 3 days
measure: Inflammation
timeFrame: biological marker of inflammation levels assessed every day during baseline, sleep restriction and recovery at 08 AM
Other outcomes:
Locations:
city: Brétigny sur Orge
country: France
facility: Institut de recherche biomédicale des armées
Study officials:
affiliation: Institut de recherche biomédicale des armées
name: Fabien SAUVET, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rabat A, Gomez-Merino D, Roca-Paixao L, Bougard C, Van Beers P, Dispersyn G, Guillard M, Bourrilhon C, Drogou C, Arnal PJ, Sauvet F, Leger D, Chennaoui M. Differential Kinetics in Alteration and Recovery of Cognitive Processes from a Chronic Sleep Restriction in Young Healthy Men. Front Behav Neurosci. 2016 May 23;10:95. doi: 10.3389/fnbeh.2016.00095. eCollection 2016.
citation: Sauvet F, Drogou C, Bougard C, Arnal PJ, Dispersyn G, Bourrilhon C, Rabat A, Van Beers P, Gomez-Merino D, Faraut B, Leger D, Chennaoui M. Vascular response to 1 week of sleep restriction in healthy subjects. A metabolic response? Int J Cardiol. 2015;190:246-55. doi: 10.1016/j.ijcard.2015.04.119. Epub 2015 Apr 16.
Clinical trial NCT04237441: The Results of Pancreatic Operations After the Implementation of Multidisciplinary Team Conference (MDT):
Official title: The Results of Pancreatic Operations After the Implementation of Multidisciplinary Team Conference (MDT): A Quality Improvement Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Neoplasms
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2020-01-23
Enrollment: 7294
Sex: ALL
Minimum age (years): 20
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all gender referred to MDT all gender not referred to MDT

Brief summary: Background: Centralization has improved the outcome of complex operations including cancer surgery. Moreover, the implementation of multidisciplinary team conferences (MDT) has ameliorated the decision making, but the impact on patient outcome is controversial. The aim of the study was to investigate the outcome of pancreatic surgery in the setting of centralization and upfront multidisciplinary decision making.

Detailed description: Study is a retrospective register study from a prospective database over MDT conferences and patient outcome. End points are quality evaluation regarding postoperative complications and mortality and long-term survival of patients radically operated for pancreatic cancer.

Eligibility criteria: Inclusion criteria: all gender seen at multidisciplinary team conference (MDT) Exclusion criteria: all gender not seen at MDT -

-

Primary outcomes:
measure: complications following pancreatic surgery
timeFrame: 14 years
measure: survival following pancreatic surgery
timeFrame: 14 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Rigshospitalet, Denmark
name: carsten hansen, DMSc
role: PRINCIPAL_INVESTIGATOR
References: