louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03010904: The Effect of Pasteurized; Pasteurized and Homogenized and UHT Treated Homogenized Cow's Milk on Gastrointestinal Symptoms in Sensitive Adults
Official title: The Effect of Pasteurized; Pasteurized and Homogenized and UHT -Treated Homogenized Cow's Milk on Gastrointestinal Symptoms in Sensitive Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unidentified Gastrointestinal Discomfort Following Dairy Consumption
Lead sponsor: University of Turku
Sponsor class: OTHER
First posted: 2017-01-05
Enrollment: 14
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: This study aims to investigate differences in digestion rates and gastrointestinal problems caused by pasteurized; pasturized and homogenized as well as UHT-treated homogenized cow's milks in healthy adults by diary of symptoms, blood glucose and triacylglycerol levels and plasma cytokine levels.


Eligibility criteria: Inclusion Criteria:

* Homogenized and pasteurized milk causes gastrointestinal problems (self-reported) unhomogenized and unpasteurized milk does not cause gastrointestinal problems (self-reported)
* age 18-65
* BMI 18,5 - 30
* hemoglobin under normal range
* fasting plasma alanine aminotransferase ALAT \< 60 U/l (normal liver function)
* fasting plasma thyroid-stimulating hormone (TSH) 0.4 - 4.5 mU/l (normal thyroid function)
* fasting plasma creatinine \< 118 umol/l (normal kidney function)

Exclusion Criteria:

* pace maker
* Crohn's disease or other disease of the intestinal tract
* intestinal operation within the last 3 months
* difficult dysphagia
* smoking
* constipation
* lactose intolerance
* coeliac disease

Primary outcomes:
measure: Gastrointestinal symptoms (self reported)
timeFrame: day 0 - day 5
Secondary outcomes:
measure: Plasma triacylglycerols
timeFrame: 20 min, 40 min, 60 min, 120 min, 180 min, 240 min, 300 min
measure: Plasma glucose
timeFrame: 20 min, 40 min, 60 min, 120 min, 180 min, 240 min, 300 min
measure: Plasma insulin
timeFrame: 20 min, 40 min, 60 min, 120 min, 180 min, 240 min, 300 min
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Department of Biochemistry, University of Turku
city: Turku
country: Finland
facility: Food Chemistry, Department of Biochemistry, University of Turku
Study officials:
affiliation: Department of Biochemistry, University of Turku
name: Kaisa M Linderborg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05785104: Effect of Muscle Energy Technique Versus Myofascial Release on Cervical and Lumbar Pain
Official title: Effect of Muscle Energy Technique Versus Myofascial Release on Cervical and Lumbar Pain in Premenopausal Women With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Pain Syndrome
Cervical Pain
Keywords: Cervical pain,lumbar pain,fibromyalgia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 74
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups, one group will be treated by muscle energy technique and other will be treated by myofascial release
Primary purpose: TREATMENT

Brief summary: The aim of the study is to determine the effect of muscle energy technique versus myofascial release on cervical and lumbar pain in premenopausal women with fibromyalgia

Detailed description: Fibromyalgia is an idiopathic, non articular pain syndrome with generalized tender points. It is multisystem disease characterized by sleep disturbance and fatigue. It affect 5% of the world population. The incidence is higher in women than in men. And the age is between 30 and 35 years old.

Eligibility criteria: Inclusion Criteria:

* Premenopausal women with fibromyalgia
* Ages ranges between 30 - 45 years old
* Body mass index \< 35 kg/m2
* All are medically stable

Exclusion Criteria:

* specific cervical and lumbar pain
* Smokers
* Pregnant women
* Medically unstable
* Postmenopausal women

Primary outcomes:
measure: Fibromyalgia impact questionnaire
timeFrame: Four weeks
measure: Visual analogue scale
timeFrame: Four weeks
measure: Active range of motion of cervical and lumbar regions
timeFrame: Four weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT03114904: Comparison of the Efficacy of a Protocol for the Withdrawal of Neurosedation From the Usual Strategy in Cerebroses
Official title: Comparison of the Efficacy of a Protocol for the Withdrawal of Neurosedation From the Usual Strategy in Cerebroses: Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Withdrawal Syndrome
Cerebral Lesion
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2017-04-14
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The withdrawal syndrome in benzodiazepines and morphine is common in intensive care, the incidence is estimated at 32.1%.

Cerebrospatized patients are probably more prone to withdrawal because they require high doses of sedation.

Moreover, this syndrome is probably deleterious on the cerebral hemodynamics (high point of the therapeutic management).


Eligibility criteria: Inclusion Criteria:

* Major Patient
* Admitted in Neuroreanimation
* Cerebroséé (TC-HSA-AVC)
* Mono or multi failing
* After a neurosedation ≥ 3 days by hypnotic type benzodiazepine (Midazolam®) and morphinomimetic (Sufentanyl®) in IVSE
* Affiliation to Social Security
* Agreement of the person of confidence

Exclusion Criteria:

* Addiction to opiates, cocaine or cannabis
* Neurological Pathology Before Hospitalization
* Patient suffering from cardiac arrest
* Pregnant woman
* Sedation window
* Patient under tutelage or curatorship or deprived of public law

Primary outcomes:
measure: A variation of the Jasinski score between H0 (stop sedation) and H6. This score measures the signs of withdrawal
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
state: Picardie
Study officials:
References:
Clinical trial NCT00344604: The Role of Psychosocial and Other Quality of Life Parameters in Evaluating Functional Changes Prior to and Following Laser In-situ Keratomileusis (LASIK)Changes Laser In-situ Keratomileusis (LASIK)
Official title: The Role of Psychosocial and Other Quality of Life Parameters in Evaluating Functional Changes Prior to and Following Laser In-situ Keratomileusis (LASIK)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Keratomileusis, Laser In Situ
Keywords: Patients who have undergone routine LASIK as a primary refractive procedure for myopia, hyperopia, or astigmatism.
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2006-06-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: To evaluate the changes in quality of life parameters after LASIK surgery.

Detailed description: Our purpose is to evaluate the changes in quality of life parameters after LASIK surgery. We intend to create a questionnaire to delineate the changes that occur in LASIK patients at the pre-operative visit and at the 1-month and 3-month post-operative visits. Additional questionnaires will be administered to demonstrate the validity of the new questionnaire. The approximate time the patient will be required to spend in clinic will be approximately 45 minutes at each of the three visits.

Eligibility criteria: Inclusion Criteria: All refractive surgery patients with otherwise normal eyes undergoing routine LASIK as a primary refractive procedure for myopia, hyperopia or astigmatism.

-

Exclusion Criteria: Patients who elect to perform alternative refractive surgery such as PRK, RK, or Intacts™.

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center at Dallas
state: Texas
Study officials:
affiliation: University of Texas, Southwestern Medical Center at Dallas
name: Shady Awwad, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01231204: Prevention of Post-Mastectomy Breast Pain Using Ambulatory Continuous Paravertebral Blocks
Official title: Prevention of Post-Mastectomy Breast Pain Using Ambulatory Continuous Paravertebral Blocks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Paravertebral Catheter Insertion
Mastectomy
Breast Cancer
Keywords: Breast Cancer
Mastectomy
UCSD
Surgery
PVB Catheter
Paravertebral Catheter
Breast Pain
Mastectomy Pain
Postoperative Pain
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2010-11-01
Enrollment: 60
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: Research study to determine if putting local anesthetic-or numbing medication-through a tiny tube placed next to the nerves that go to a breast prior to and following a mastectomy will decrease subsequent pain.

Detailed description: Specific Aim 1: To determine if, compared with current and customary analgesia, the addition of a multiple-day ambulatory continuous paravertebral block decreases the incidence and severity of post-mastectomy pain.

Hypothesis 1: Following mastectomy, the incidence and severity of breast pain will be significantly decreased in the week following surgery with a multiple-day ambulatory continuous paravertebral block as compared with patients receiving standard-of-care treatment (as measured on the 11-point numeric rating scale).

Hypothesis 2: Following mastectomy, the incidence and severity of chronic pain will be significantly decreased three months following multiple-day ambulatory continuous paravertebral blocks as compared with patients receiving standard-of-care treatment (as measured on the 11-point numeric rating scale).

Eligibility criteria: Inclusion Criteria:

* undergoing unilateral or bilateral mastectomy
* desiring analgesia with a paravertebral nerve block(s)
* age 18 years or older
* female

Exclusion Criteria:

* morbid obesity as defined by a body mass index \> 40
* renal insufficiency
* chronic opioid use
* history of opioid abuse
* any comorbidity which results in moderate or severe functional limitation
* inability to communicate with the investigators or hospital staff
* pregnancy
* incarceration

Primary outcomes:
measure: Pain Scores (NRS)
timeFrame: Day following Surgery
Secondary outcomes:
measure: Pain scores
timeFrame: First 4 postoperative days
measure: Opioid Requirements
timeFrame: First 4 postoperative days
measure: Opioid-related side effects
timeFrame: First 4 postoperative days
measure: Sleep Disturbances
timeFrame: First 4 postoperative days
measure: Cancer Recurrence
timeFrame: One Year following Surgery
measure: Pain and Physical Functioning
timeFrame: Within first year of surgery
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD Thornton Hospital
state: California
Study officials:
affiliation: University of California, San Diego, Department of Anesthesia
name: Brian M Ilfeld, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05809804: Median Effective Dose of Esketamine Pretreatment to Prevent Sufentanil-induced Cough
Official title: Median Effective Dose of Esketamine Pretreatment to Prevent Sufentanil-induced Cough
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sufentanil
Esketamine
Lead sponsor: Yangzhou University
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Sufentanil has the advantages of fast onset time, strong analgesic function and cardiovascular stability, and is widely used during general anesthesia induction. However, sufentanil can cause cough during induction of general anesthesia. Different studies have reported that the incidence of sufentanil-induced cough ( SIC ) during anesthesia is 16-42 %. This pathological condition may lead to damage to the central nervous system, increase the risk of reflux and aspiration, increase intracranial pressure and intraocular pressure, and endanger patients with cerebral aneurysms and ocular trauma. Therefore, at the moment of advocating comfortable anesthesia medical services, sufentanil-induced cough response is a problem that clinical anesthesiologists need to focus on and urgently solve. It has been reported that ketamine can reduce the incidence of cough caused by opioids. Esketamine is a pure dextro-enantiomer of ketamine and an NMDA antagonist with potent analgesic and bronchodilator effects. In this study, Dixon sequential method was used to study the median effective dose ( ED50 ) of intravenous esketamine pretreatment to prevent sufentanil-induced cough, and to explore the effect of age on ED50. To provide reference for clinical rational selection of esketamine dose.


Eligibility criteria: Inclusion Criteria:

ASA I-II patients aged 18-59 years undergoing elective surgery under general anesthesia

Exclusion Criteria:

1. Preoperative intracranial pressure;
2. intra-abdominal pressure or intraocular pressure increased ;
3. have a history of cardiovascular and cerebrovascular diseases ;
4. have a history of asthma ;
5. have a history of chronic cough ;
6. have a history of smoking ;
7. there was a history of upper respiratory tract infection 2 weeks before operation;
8. Patients received opioid therapy 2 weeks before surgery.;
9. Patients who received angiotensin converting enzyme inhibitors, bronchodilators or steroids 2 weeks before surgery ;
10. abnormal liver and kidney function ; weight exceeded 20 % of the ideal weight ( male height - 100, female height - 105 ).

Primary outcomes:
measure: The presence of cough
timeFrame: an average of 1 minutes
Secondary outcomes:
measure: The levels of cough
timeFrame: an average of 1 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03490604: Ambulatory Measurement of Physical Activity in Pancreatic Cancer Patients
Official title: Ambulatory Measurement of Physical Activity in Pancreatic Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Unresectable Pancreatic Adenocarcinoma
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2018-04-06
Enrollment: 30
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: patients followed in the hospital unit

Brief summary: Pancreatic cancer is the 5th leading cause of death from cancer in France. When chemotherapy can be proposed, the choice of treatment is currently based on the patient's profile and expected tolerance. The endpoints currently used in trials, such as time to therapeutic failure, do not take into account the patient's experience of the disease. The use of quality of life questionnaires is often proposed, but frequent missing data and filling time can be a problem. In oncology, some studies have demonstrated, through questionnaires, the link between physical activity and quality of life. In this situation, ambulatory measurement of physical activity by wrist actimetry could be an integrative reflection of the impact of the disease and treatment (efficacy, tolerance) on patients. This type of evaluation, if accepted by patients, could usefully complement the measurement of quality of life in this population. No study has specifically looked at the use of devices of this type in the context of digestive cancer. The investigators propose to evaluate the acceptance of this type of device by pancreatic cancer patients receiving chemotherapy before evaluating its potential interest.


Eligibility criteria: Inclusion Criteria:

* Patient with unresectable pancreatic adenocarcinoma for whom an indication for chemotherapy has been decided upon after a multidisciplinary consultation meeting;
* Adult patient;
* Patients able to understand spoken and written French,
* Patient has given consent.

Exclusion Criteria:

* WHO ECOG stage III or IV ;
* Patient suffering from a major physical disability (hemiplegia, paraplegia, myopathy, amputation of a limb);
* Any alteration of comprehension capacities making self-evaluation impossible;
* Protected adult;
* Patient not affiliated to a national health insurance scheme;
* Pregnant or nursing women.

Primary outcomes:
measure: average time wearing the accelerometer, in hours
timeFrame: every 2 weeks for 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourogne
Study officials:
References:
Clinical trial NCT03009604: Does Simethicone Improve Operative Field in Gynecological Operations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Benign Gynecologic Neoplasm
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-01-04
Enrollment: 90
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Mechanical bowel preparation aims to decrease the volume fecal content in the colon, which thereby decreases the total colony count of bacteria, thus, decreasing peritoneal contamination in case of bowel injury, improving the access to the surgical field and facilitating intraoperative bowel manipulation


Eligibility criteria: Inclusion Criteria:

Gynecological operations for benign conditions as hysterectomy, ovarian cystectomy and myomectomy.

Exclusion Criteria:

1. History of allergic reaction to study drugs.
2. More than one scar of previous operation.
3. Suspicious of malignancy.
4. Psychiatric disorders.

Primary outcomes:
measure: the degree of small & large bowel preparation
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References:
Clinical trial NCT01073904: Cross-over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel 1.5 mg
Official title: Open-label, Randomized, Crossover Study to Prove the Bioequivalence Between Opxion® (Levonorgestrel 1.5 mg Coated Tablet From Bayer de Mexico) and Postinor 2® (Levonorgestrel 1.5 mg Tablet From Biofarma Natural CMD) in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Contraceptives, Postcoital
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-02-23
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: A single dose, two treatments (Postinor-2 and Opxion), two periods, two sequences, crossover, randomized, prospective design was chosen with a washout of 14 days between the two study periods. Treatment groups are balanced with the same number of male healthy volunteers who were randomly assigned to the study drug administration sequences.


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers age between 18 and 55 years old with normal vital signs, electrocardiogram (ECG), blood chemistry, liver function profile and urinalysis.

Exclusion Criteria:

* History of illnesses or any organic abnormalities that could affect the results of the study.
* History of tobacco or alcohol abuse or regular use of recreational or therapeutic drugs.
* Subjects that have taken any medication within 14 days or that are in an elimination period of less than 7 half-lives (whichever is longest) before study startup.

Primary outcomes:
measure: Least square estimator of average maximum plasmatic concentration (log transformed)
timeFrame: After 2 months
measure: Least square estimator of area under the pharmacokinetic curve (log transformed)
timeFrame: After 2 months
Secondary outcomes:
measure: Time at which maximum concentration is reached
timeFrame: After 2 months
measure: Area under the pharmacokinetic curve from time=0 to last blood sample
timeFrame: After 2 months
measure: Half life of plasmatic concentration of study drug
timeFrame: After 2 months
measure: Clearance constant of plasmatic concentration of study drug
timeFrame: After 2 months
measure: Adverse events collection
timeFrame: Up to 8 weeks
Other outcomes:
Locations:
city: Morelia
country: Mexico
state: Michoacán
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04642404: CBD for Dental Pain
Official title: Cannabidiol (CBD) for the Management of Emergency Dental Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Odontalgia
Toothache
Keywords: Cannabidiol (CBD)
Opioid
Dose
Dental
Pain
Epidiolex
CBD
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2020-11-24
Enrollment: 64
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 purpose of this study is to evaulate CBD as a therapeutic approach for dental pain. Eligible subjects presented with emergency dental pain will be give a single dose of Epidiolex (FDA-approved CBD) or placebo and will be monitored for 3 hours for pain symptoms and psychologic effects.

Detailed description: CBD is a non-psychoactive, non-addictive compound of cannabis that has shown analgesic and anti-inflammatory properties. Epidiolex is the only FDA-approved oral CBD solution and will be the drug of choice in this study.

Eligibility criteria: Inclusion Criteria:

* Healthy adults 18-75 years old, ASA I or II
* permanent tooth with moderate to severe odontogenic pain, i.e. ≥30 on a 100mm VAS,
* clinical pulpal diagnosis of irreversible pulpitis or pulpal necrosis, and periapical diagnosis of symptomatic apical periodontitis
* test negative for recent cannabis use and/or other drugs of abuse including alcohol (urine tests collected at screening visit), and participant
* able to understand the forms (English or Spanish) and provide informed written consent.

Exclusion Criteria:

* ASA Class III or IV
* patients with hepatic impairment
* pregnant or lactating women
* Patients on drugs metabolized by enzymes that also metabolize CBD (e.g. clobazam, diazepam, topiramate, warfarin)
* self-reported prior experience inhaling cannabis (either via smoking or vaporization), use of opioids in the month prior to screening/treatment visit, and/or NSAIDS or acetaminophen 6 hours prior to treatment
* unwilling to participate.

Primary outcomes:
measure: Intra-group VAS Pain Intensity and Maximum Pain Relief
timeFrame: Baseline to 180 minutes
measure: Bite Force Measurement
timeFrame: Baseline, 90 minutes and 180 minutes
Secondary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 3 hours and 7 Days
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: University of Texas Health Science Center San Antonio
name: Vanessa Chrepa, DDS MS
role: PRINCIPAL_INVESTIGATOR
References: