louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03729505: Impact of Pyloric Injection of Magnesium Sulfate and Lidocaine Mixture on Outcome After Sleeve Gastrectomy
Official title: Impact of Pyloric Injection With Magnesium Sulphate and Lidocaine Mixture on Early Postoperative Outcome After Laparoscopic Sleeve Gastrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2018-11-02
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Postoperative nausea and vomiting is a common adverse effect after sleeve gastrectomy, mostly due to increased intragastric pressure. The present trial aimed to assess the effect of pyloric injection of mixture of magnesium sulfate and lidocaine on postoperative gastric intraluminal pressure and incidence of nausea and vomiting.


Eligibility criteria: Inclusion Criteria:

* Patients that aged between18 and 65 years.
* American Society of Anesthesiologists (ASA) class I - III.
* Morbidly-obese patients who failed to achieve and maintain a clinically significant weight loss through supervised non-surgical methods for at least 6 months.
* Surgery was conducted as the first line of treatment in case of patients with BMI ≥ 50 kg/m2 (super obese).

Exclusion Criteria:

* Obesity secondary to endocrine disorders.
* History of any previous bariatric procedure.
* Impaired intellectual capacity or major psyciatric disorder.
* Sweet eaters who would not adopt a change of postoperative eating habits.
* Lack of willingness and motivation to embrace postoperative lifestyle changes.
* Substance abuse.
* Pregnancy or expected pregnancy in the following 12 to 18 months.
* Severe gastroesophageal reflux disease

Primary outcomes:
measure: Postoperative nausea and vomiting
timeFrame: first 24 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura university hospital
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Sameh H Emile
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06417905: Effect of Exercises on Dentists' Body Functions
Official title: Effects Of Exercise Training On Core Endurance, Scapular And Upper Exstremity Functions in Dentists
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: muscle strength
muscle endurance
pain
neck pain
musculoskeletal problems
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
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 effects of supervised exercises, video based exercises and control group on muscle strength, muscle endurance, pain and upper extremity function in dentists with musculoskeletal pain. Participants were randomly divided into 3 groups: Supervised exercise group (SEG), video based exercise group (VEG) and control group (CG). Both SEG and VEG were given same exercises but SEG did the exercises with a experienced physiotherapist while VEG did it through videos 3 days a week for 12 weeks. CG was only given postural education.


Eligibility criteria: Inclusion Criteria:

* working as an active dentist for at least 3 years
* Having nonspecific neck pain more than 3 months

Exclusion Criteria:

* any operation in neck area

Primary outcomes:
measure: Change in pain
timeFrame: Before training and after 12 weeks of training
Secondary outcomes:
measure: change in deep cervical flexor and extensor muscle endurance
timeFrame: Before training and after 12 weeks of training
measure: change in scapular muscle endurance
timeFrame: Before training and after 12 weeks of training
measure: change in core static and dynamic endurance
timeFrame: Before training and after 12 weeks of training
measure: functional assessment
timeFrame: Before training and after 12 weeks of training
measure: neck disability
timeFrame: Before training and after 12 weeks of training
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Dokuz Eylul University
Study officials:
References:
Clinical trial NCT06070805: Impact and Mechanism of Depression on Cardio-cerebral Vascular Events and Arteriovenous Fistula Dysfunction in MHD Patients
Official title: The Impact and Mechanism of Depression on Cardio-cerebral Vascular Events and Arteriovenous Fistula Dysfunction in Hemodialysis Patients: A Single Center and Real-world Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardio-cerebral Vascular Events
Arteriovenous Fistula Dysfunction
Keywords: maintenance hemodialysis patients
depression
cardio-cerebral vascular events
arteriovenous fistula dysfunction
platelet
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2023-10-06
Enrollment: 286
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing maintenance hemodialysis were recruited from the First Affiliated Hospital of Chongqing Medical University in China.

Brief summary: Depression is a common psychiatric disorder in patients on maintenance hemodialysis (MHD). It may contribute to poor prognosis in a number of ways, including its effect on platelet function. We aimed to investigate the impact and underlying mechanisms of depression on the occurrence of cardio-cerebral vascular events (CCVE) and dysfunction of arteriovenous fistula (DAVF) in MHD patients.

In this study, MHD patients were recruited and divided into depression and non-depression groups using the Hamilton Depression Scale (HAMD) in this prospective cohort study. Their clinical and laboratory indicators were collected and the occurrence of CCVE and DAVF were recorded through clinical follow-up, and analyzed, and the differences and possible influencing factors of CCVE and DAVF occurrence were assessed between the two groups of patients.


Eligibility criteria: Inclusion Criteria:

* Patients had undergone dialysis treatment for more than 3 months, and their medical status was stable at the time of enrollment, with an expected survival period of more than 1 year

Exclusion Criteria:

* (1) with communication disorders or mental illness other than depression; (2) a combination of cirrhosis, lymphoma, thrombocytopenic purpura, or other diseases that significantly affect platelet function; (3) complicated with malignant tumors, tuberculosis, severe heart failure, and unstable medical conditions; (4) inability or unwillingness to cooperate with researchers.

Primary outcomes:
measure: cardio-cerebral vascular events (CCVE)
timeFrame: 1 year
measure: dysfunction of arteriovenous fistula (DAVF)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Yunfeng Xia, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT01449305: Effectiveness of Nanoone Woman Underwear Using in the Management of Dysmenorrhea
Official title: Research on Effectiveness of Nanoone Woman Underwear Using in the Management of Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysmenorrhea
Lead sponsor: Chen Yi Enterprise, Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-10-10
Enrollment: 44
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To evaluate the mean change in menstrual pain intensity during menstrual cycles from baseline after wearing Nanoone Woman Underwear in women with primary dysmenorrhea

Detailed description: The severity of dysmenorrhea pain experienced by subjects will be evaluated on a VAS, ranging from zero (no pain) to ten (very severe pain). Subjects will be asked to use the VAS scoring system to record, on a provided sheet, their experienced menstrual pain level daily during menstrual bleeding for a total of three consecutive menstrual cycles.

Eligibility criteria: Inclusion Criteria:

1. Females aged below 40 years old.
2. Screened by inquiry and diagnosed as primary dysmenorrhea by gynaecologist with pelvic ultrasonography.
3. Female subject who is:

   * using adequate contraception since last menstruation and no plan for conception during the study.
   * non-lactating.
   * has negative pregnancy test (urine) within 14 days prior to the study.
4. Informed consent form signed.

Exclusion Criteria:

1. Sensitivity to study product.
2. Patient has been diagnosed with secondary dysmenorrhea (defined as identifiable pelvic pathology).
3. Patient has clinically significant physical disability or abnormal findings on physical examination or laboratory testing judged by the investigator or co-investigator.
4. Participation of any clinical investigation during the last 30 days.

Primary outcomes:
measure: The Mean Change in Maximum Pain Level at Each Menstrual Cycle From Baseline
timeFrame: baseline, first menstrual cycle, second menstrual cycle and third menstrual cycle
Secondary outcomes:
Other outcomes:
measure: Medicine Administration for Pain Relief During Study Period
timeFrame: first menstrual cycle, second menstrual cycle and third menstrual cycle
Locations:
city: Pingtung
country: Taiwan
facility: PingTung Christian Hospital
Study officials:
References:
Clinical trial NCT03745105: Comparative Evaluation of the Effect of Prophylactic Intraligamentary Injection of Dexamethasone and Piroxicam on Postoperative Pain in Teeth With Symptomatic Irreversible Pulpitis
Official title: Comparative Evaluation of the Effect of a Prophylactic Intraligamentary Injection of Dexamethasone and Piroxicam on Postoperative Pain in Teeth With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-11-19
Enrollment: 42
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the study is conducted to assess and compare the efficacy of local intraligamentary injection of glucocorticoids(dexamethasone) and NSAID(piroxicam) on reduction of postoperative pain in patients with symptomatic irreversible pulpitis.


Eligibility criteria: Inclusion Criteria:

1. Systemically healthy patient (ASA I or II).
2. Mandibular Posterior teeth with:

   * Preoperative sharp pain.
   * Absence of widening in the periodontal ligament (PDL).
   * Vital response of pulp tissue to cold pulp tester (ethyl chloride spray).

Exclusion Criteria:

1. Patients allergic to anesthetics, piroxicam (any other NSAIDs) or dexamethasone (other corticosteroids).
2. Pregnant or nursing females.
3. Patients having significant systemic disorder (ASA III or IV).
4. Hemostatic disorders or anti-coagulant therapy during the last month.
5. Consumption of opioid or non-opioid analgesics or corticosteroids during the last 12 hrs before treatment.
6. Retreatment cases.

Primary outcomes:
measure: Post operative pain assessed with the Numerical Rating Pain Scale
timeFrame: up to 48 hours after root canal treatment (At 4,6,12,24 and 48 hours after root canal treatment ).
Secondary outcomes:
measure: number of analgesics taken by the patient
timeFrame: Until 48 hours after endodontic treatment.
Other outcomes:
Locations:
Study officials:
References:
citation: Mehrvarzfar P, Esnashari E, Salmanzadeh R, Fazlyab M, Fazlyab M. Effect of Dexamethasone Intraligamentary Injection on Post-Endodontic Pain in Patients with Symptomatic Irreversible Pulpitis: A Randomized Controlled Clinical Trial. Iran Endod J. 2016 Fall;11(4):261-266. doi: 10.22037/iej.2016.2.
citation: Atbaei A, Mortazavi N. Prophylactic intraligamentary injection of piroxicam (feldene) for the management of post-endodontic pain in molar teeth with irreversible pulpitis. Aust Endod J. 2012 Apr;38(1):31-5. doi: 10.1111/j.1747-4477.2010.00274.x. Epub 2010 Oct 24.
Clinical trial NCT05710705: Bioimpedance Measurement of Abdominal Free Flaps During Arterial and Venous Weaning in Breast Reconstruction
Official title: Bioimpedance Measurement of Abdominal Free Flaps During Arterial and Venous Weaning in Breast Reconstruction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Reconstruction
Thrombosis, Venous
Bioimpedance Measurement Capacity
Keywords: breast reconstruction
Thrombosis, Venous
bioimpedance measurement capacity
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: As the occurrence of thrombosis in post surgery is rare, it seemed difficult to study only this one. This is why we decided to test the bioimpedance, temperature and green, red and infrared light absorption measurements of the prototype during the weaning of the flap during surgery. Indeed, during weaning the investigators voluntarily interrupt the arterial and venous flow to transfer the flap to the breast. This weaning corresponds to a thrombosis model.

The patients will benefit from an "improved" postoperative monitoring. Indeed, in addition to the classical clinical monitoring, they will benefit from an additional monitoring during 5 days thanks to the realization of an ultrasound of the flap which will be carried out every 6 hours the first 24 hours then every 12 hours.

This protocol is therefore a feasibility study for the collection of data of interest.


Eligibility criteria: Inclusion Criteria:

* Woman undergoing microsurgical breast reconstruction using a free abdominal flap
* Age greater than or equal to 18 years

Exclusion Criteria:

* Pregnant patient
* Patient with an active implantable device such as a pacemaker or an artificial heart
* Patient refusing to participate in the study
* Age less than 18 years old

Primary outcomes:
measure: Measurement of impedence
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT04926805: Physiological Study to Compare Noninvasive Ventilation (NIV) Masks
Official title: Physiological Study to Compare Noninvasive Ventilation (NIV) Masks
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sleep-disordered Breathing
Hypercapnia
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2021-06-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Noninvasive ventilation (NIV) is an established therapy that delivers positive pressure to the upper airways to provide respiratory support. Two types of NIV can be delivered; continuous positive airway pressure (CPAP) at one continuous pressure and bilevel NIV at two pressures for inhalation and exhalation.

This investigation is designed to physiologically evaluate the performance of a NIV mask, Mask A, compared to a standard NIV mask, Mask B on CPAP therapy.

People with sleep disordered breathing who have chronic hypercapnia, and are already receiving nocturnal CPAP will be recruited. They will receive one night's CPAP therapy on Mask A and 1 night on Mask B in random order. Physiological parameters will be recorded.

Parameters will be recorded during three baselines at the beginning of each evening and throughout the night when participants are asleep. The three baselines are:

1. participant awake with normal breathing (not on CPAP),
2. participant awake and on CPAP, and
3. participant asleep on CPAP in REM-sleep (rapid eye movement sleep).


Eligibility criteria: Inclusion Criteria:

* Already using overnight CPAP and tolerating the therapy well (over 4 hours use/night)
* Hypercapnia: venous bicarbonate of 30 milliequivalents of solute per liter (Eq/L) or more, OR transcutaneous carbon dioxide (TcCO2) of 50 millimeters of mercury (mmHg) of more.
* Provide written informed consent
* Already use a full (oronasal) face mask for CPAP
* Willing to have a venous blood sample taken during the pre-screening visit.

Exclusion Criteria:

* Presence of sleep apnea on CPAP:

  * Subjects excluded if they have an apnea-hypopnea index (AHI) of more than 20, or
  * If the AHI has not already decreased by 50 percent or more from pre-CPAP to with CPAP.
* Forced expiratory volume in 1 second (FEV1) of less than 40 percent of predicted.
* Forced expiratory volume in 1 second divided by forced vital capacity (FEV1/FVC) less than fifty percent of predicted, at the screening visit.

  * Have poorly controlled asthma or changing asthma symptoms.
  * Nasal obstruction
  * Do not fit Mask A or Mask B
  * Agitation or psychological illness

Primary outcomes:
measure: Transcutaneous carbon dioxide
timeFrame: 1 day (From baseline to the end of the study night)
Secondary outcomes:
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: New Zealand Respiratory and Sleep Institute
Study officials:
affiliation: New Zealand Respiratory and Sleep Insitute
name: Andy Veale, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01146405: Memory During Anesthesia: the Role of Stress Hormones
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Surgical Procedure, Unspecified
Keywords: Laparoscopic
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2010-06-17
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients sheduled for minor elective laparoscopic surgery

Brief summary: 1. To investigate whether the auditory stimulation causes changes in hormones levels (cortisol+prolactin) during general anesthesia.
2. To determine if there is a correlation between hormones levels (cortisol+prolactin) and dreams recall.
3. To investigate whether, in patients receiving auditory stimulation, there is a correlation between hormones levels (cortisol+prolactin), serum remifentanil concentration and detection of implicit memory.
4. To investigate the presence of primary auditory cortex activation (temporal lobe) in patients with implicit memory and in those with dreams recall using the EEG-ERP 128 channels GES300 EGI system.

Detailed description: Patients from group A, during maintenance of anesthesia, at the time of trocar insertion, will listen (via MP3) a piece of one of two stories, "Puss in Boots" and "Pinocchio", each followed by four keywords. In group B, patients will be isolated from the sounds of the operating room using specific headphones.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 70 years old
* Class-ASA Physical Status I-II

Exclusion Criteria:

* Psychiatric or neurological disorders and/or hearing disorders
* Obesity (Body Mass Index \> 30)
* Drug addiction, alcoholism
* Patients with an education level below middle school
* Patients with difficulty in understanding the Italian language
* Patients treated with corticosteroids and/or estrogens, pregnant patients and patients suffering from hypercorticism

Primary outcomes:
measure: Hormones levels
timeFrame: 5 minutes after achieving a pneumoperitoneum pressure of 12 mmHg
measure: Hormones levels
timeFrame: Baseline
Secondary outcomes:
measure: Remifentanil concentration
timeFrame: 5 minutes after achieving a pneumoperitoneum pressure of 12 mmHg
measure: Memory
timeFrame: Approximately 24 hours after surgery for explicit memory, implicit memory and for dreams recall detected after awakening from anesthesia
measure: Primary auditory cortex activation
timeFrame: 5 minutes after achieving a pneumoperitoneum pressure of 12 mmHg
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Catholic University of Sacred Heart
Study officials:
References:
Clinical trial NCT00196105: Malignant Obstruction ZILVER Against Routine Therapy (MOZART I)
Official title: Multicenter Prospective Randomized Controlled Trial of the Nitinol ZILVER Expandable Endoprosthesis in the Palliation of Extrahepatic Malignant Biliary Obstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biliary Tract Neoplasms
Pancreatic Neoplasms
Jaundice, Obstructive
Keywords: Stents
Stent-graft
Minimally invasive
Biliary Tract Cancer
Pancreatic Cancer
Jaundice
Biliary Tract Neoplasms
Pancreatic Neoplasms
Jaundice, Obstructive
Zilver
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 241
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares the 6 mm nitinol Zilver biliary endoprostheses and the 10 mm nitinol Zilver biliary endoprostheses to the 10 mm Wallstent in appropriate patients in need of palliative treatment of malignant obstructive jaundice.

Detailed description: This research is being done to determine if the new, FDA-cleared Zilver metal biliary stent is better than the conventional stents. The new Zilver stent may permit more accurate placement, may avoid some potential complications and last longer than the conventional stents. The study will also examine to find the best diameter of stent by comparing standard 10 mm stents to 6 mm Zilver stents.

Eligibility criteria: Inclusion Criteria:

* Unresectable malignancy of the extrahepatic bile duct

Exclusion Criteria:

* Age below 21 years
* Pregnancy
* Active alcohol or drug abuse
* Simultaneously participating in another investigational drug or device study.
* Allergy to stainless steel or nitinol
* Active cholangitis
* Brachytherapy
* Unable or unwilling to comply with follow up

Primary outcomes:
measure: Patency
timeFrame: up to 32 months
measure: Closure or Blockage of the Stent (Occlusion)
timeFrame: up to 32 months
measure: Number of Days to Occlusion
timeFrame: up to 32 months
measure: Number of Deaths
timeFrame: up to 32 months
measure: Time to Death
timeFrame: up to 32 months
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
Study officials:
affiliation: MaineHealth
name: Douglas Howell, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Loew BJ, Howell DA, Sanders MK, Desilets DJ, Kortan PP, May GR, Shah RJ, Chen YK, Parsons WG, Hawes RH, Cotton PB, Slivka AA, Ahmad J, Lehman GA, Sherman S, Neuhaus H, Schumacher BM. Comparative performance of uncoated, self-expanding metal biliary stents of different designs in 2 diameters: final results of an international multicenter, randomized, controlled trial. Gastrointest Endosc. 2009 Sep;70(3):445-53. doi: 10.1016/j.gie.2008.11.018. Epub 2009 May 30.