louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05518006: An Investigation of Premama Balance and Its Effects on Hormonal Imbalances
Official title: An Exploratory Investigation of Dietary Supplementation and the Effect on the Regularity of Menstrual Cycles, Hormone Balance, and Common PMS Symptoms in Females
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: PMS
Menstrual Discomfort
Hormone Disturbance
Menstrual Pain
Menstrual Irregularity
Keywords: PMS
Menstrual Discomfort
Hormone Disturbance
Menstrual Pain
Menstrual Irregularity
Lead sponsor: Premama Inc.
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2022-08-26
Enrollment: 0
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: An investigation of the dietary supplement marketed as "Premama Balance" on markers of subjective wellbeing in trial participants such as common symptoms of PMS and menstrual symptoms, as well as its effects on aiding in returning to their perceived regular/normal menstrual cycle.


Eligibility criteria: Inclusion Criteria:

* Must be in good health (don't report any medical conditions asked in the screening questionnaire)
* Must be on hormonal birth control (containing both progesterone and estrogen) for the past 6 months \& willing to stop using it to participate in the study
* Must be willing to get off of hormonal birth control for the study period
* Must be able to track their menstrual cycle
* BMI under 40
* Agree to refrain from any lifestyle changes that may affect their menstrual cycle for the duration of the study
* Willingness to adhere to the dietary supplement regimen
* Willingness to refrain from any other dietary supplements targeting the menstrual cycle and hormone control during the study period
* Is able to communicate in English
* Is willing and able to share feedback via the used technology portal
* Must provide written informed consent (ICF)

Exclusion Criteria:

* History of oncological (including ovarian cancer) or psychiatric conditions
* History of uncontrolled health conditions
* History of hysterectomy or ovariectomy
* History of diabetes \& thyroid disorders
* Smoker
* More than 3 servings of alcohol a day
* Undergoing hormonal therapy of any kind
* Menopausal or peri-menopausal
* Not starting any other form of contraceptive other than condoms, abstinence, planned sexual intercourse
* Usage of any medication or herbal remedies/supplements which can affect the menstrual cycle or hormonal balance
* If currently taking allowed supplements, the dosage needs to remain the same throughout the entirety of the study

Primary outcomes:
measure: Return to perceived regular/normal menstrual cycle
timeFrame: 6 Months
measure: Changes in PMS and Menstrual Symptoms: Cramps, Bloating, Mood swings
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Citruslabs
name: Susanne Mitschke
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05190406: Success and Quality of Life Following Complete Pulpotomy and Root Canal Treatment
Official title: Success and Quality of Life Following Complete Pulpotomy and Root Canal Treatment in Teeth With Clinical Signs Indicative of Irreversible Pulpitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Irreversible Pulpitis
Keywords: pulpitis
pulpotomy
single visit root canal treatment
bioceramic material
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2022-01-13
Enrollment: 100
Sex: ALL
Minimum age (years): 14
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the Success and quality of life following complete pulpotomy and root canal treatment in teeth with clinical signs indicative of irreversible pulpitis.

Detailed description: After thorough history and clinical and radiographic examination, and confirmation of eligibility for the study, risks and benefits associated with the procedure will be explained and written informed consent will be taken from the patients. Study subjects will be randomly allocated to either Complete pulpotomy or Root canal treatment Group.

Eligibility criteria: Inclusion Criteria:

* Mature permanent restorable mandibular molar teeth.
* Tooth should give positive response to pulp sensibility testing.
* Clinical diagnosis of irreversible pulpitis with PAI score≤2.
* Tooth with probing pocket depth and mobility are within normal limits.
* Non-contributory medical history.

Exclusion Criteria:

* Teeth with immature roots.
* No pulp exposure after caries excavation.
* Bleeding could not be controlled in 6 minutes.
* Insufficient bleeding after pulp exposure, the pulp is judged necrotic or partially necrotic.
* Absence of antagonist tooth.
* Positive history of antibiotic use in the past 1 month or requiring antibiotic prophylaxis
* Had taken analgesic in past 3 days.
* Tooth with periapical lesion visible on radiograph

Primary outcomes:
measure: Clinical success rate
timeFrame: 6 months and one year
measure: Radiographic success rate
timeFrame: 6 months and one year
Secondary outcomes:
measure: Oral Health related quality of Life
timeFrame: baseline to one week, 6 months and one year
measure: Pain assessment
timeFrame: baseline to one week
Other outcomes:
Locations:
city: Rohtak
country: India
facility: Post graduate institute of dental sciences
state: Haryana
Study officials:
affiliation: POST GRADUATE INSTITUTE OF DENTAL SCIENCES, ROHTAK, Haryana, India, 124001
name: Dr. Sanjay Tewari, MDS
role: STUDY_DIRECTOR
References:
Clinical trial NCT01074606: Visual Function After Implantation of AcrySof® Toric Lens
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Cataract
Keywords: Cataract
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-02-24
Enrollment: 56
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the postoperative visual function of Taiwanese patients following bilateral or unilateral AcrySof Toric Intraocular Lens (IOL) implantation.


Eligibility criteria: Inclusion Criteria:

* Prospective subjects should be adults and may be of any race and gender, and diagnosed with cataracts.
* Subject must require extraction of cataracts followed by implantation of a posterior chamber intraocular lens.
* All subjects must have between 0.75 - 2.0 Diopter (D) of astigmatism preoperatively as measured by keratometry readings.
* For any second eye surgery in bilateral AcrySof Toric patients, it should be performed at least one week following the first eye implant but no longer than one month after the first implant.

Exclusion Criteria:

* Subjects with pre-existing conditions that could skew the results should be excluded from the Study.
* AcrySof® Toric product inserts under "Precautions" for subject groups that should be excluded from this Study.

Primary outcomes:
measure: Postoperative Refractive Cylinder
timeFrame: Pre-Operative Day, 1 Month Postoperative, 3 Month Postoperative
Secondary outcomes:
measure: Uncorrected distance visual acuity (UCDVA)
timeFrame: Pre-Operative Day, 1 Month Postoperative, 3 Month Postoperative
measure: Best corrected distance visual acuity (BDCVA)
timeFrame: Pre-operative, 1 month postoperative, 3 months postoperative
Other outcomes:
Locations:
city: Changhua City
country: Taiwan
Study officials:
References:
Clinical trial NCT01278706: Endometrial Biopsy Protocol for In Vitro Fertilization (IVF)
Official title: Comparing Timing and Number of Endometrial Biopsies in IVF Treatment and Identifying Biochemical Markers to Predict Endometrial Receptivity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Recurrent Implantation Failure
Lead sponsor: Kaplan Medical Center
Sponsor class: OTHER
First posted: 2011-01-19
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Endometrial biopsy has been shown to improve IVF pregnancy and live birth rates. The optimal time of performing the biopsy is yet to be established.

In this study, the investigators will compare different temporal timing of the biopsies with regards to the menstrual cycle and their affect on the success rates of the treatment.


Eligibility criteria: Inclusion Criteria:

* normal menstrual cycle
* between 1-6 previous failed IVF cycles
* normal hormonal profile

Exclusion Criteria:

* intrauterine procedure in last 3 months
* hydrosalpinx
* intrauterine lesion /malformation

Primary outcomes:
measure: pregnancy rates
timeFrame: 2 years
Secondary outcomes:
measure: live birth rates
timeFrame: 3 years
Other outcomes:
Locations:
city: Rehovot
country: Israel
facility: Kaplan Medical Center, IVF Unit
city: Rehovot
country: Israel
facility: Weizmann Institute of Science
Study officials:
References:
Clinical trial NCT03204006: Attenuation of Hemodynamic Response to Laryngoscopy and Endotracheal Intubation With Single Dose of Dexmedetomidine in Hypertensive Patients.
Official title: Attenuation of Hemodynamic Response to Laryngoscopy and Endotracheal Intubation With Single Dose of Dexmedetomidine in Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Response During Laryngoscopy Intubation
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-06-29
Enrollment: 70
Sex: ALL
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: Attenuation of Hemodynamic Response to Laryngoscopy and Endotracheal Intubation With Single Dose of Dexmedetomidine in Hypertensive Patients.


Eligibility criteria: Inclusion Criteria:

* - Age group 20-60 years
* ASA grade 1 and 2
* control hypertensive patients.

Exclusion Criteria:

* - Consent not given
* ASA Grade 3 and 4
* history of myocardial ischemia or infarction, or had an abnormal ECG on admission to the hospital
* Patients with cardiovascular, pulmonary, hepatic, and renal disease.
* Patients on B blockers.
* patients with difficult airway; laryngoscopy and intubation time more than 20 s, or requiring more than two attempts will be exclude from the study.

Primary outcomes:
measure: heart rate
timeFrame: through first 15 min post-induction of anesthesia
Secondary outcomes:
measure: systolic blood pressure
timeFrame: through first 15 min post-induction of anesthesia
measure: diastolic blood pressure
timeFrame: through first 15 min post-induction of anesthesia
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
Study officials:
References:
Clinical trial NCT02693106: Evaluation of the Ketogenic Potential of Different Diet Supplements
Official title: Stimulating the Ketogenesis by Using Nutritional Supplements
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Adults
Keywords: Ketones
Butyrate
Leucine
Octanoate
Carnitine
Medium Chain Triglycerides
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2016-02-26
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Evaluate the capacity of different dietary supplements to increase ketone production in healthy adults.

Detailed description: The aim of this study is to evaluate the capacity of different dietary supplements to increase ketone production in healthy adults. Each supplement (leucine, butyrate, octanoate, carnitine or butter fraction rich in MCT) is evaluated for a period of 4-hour during which multiple blood samples are taken in order to measure ketone production.

Eligibility criteria: Inclusion Criteria:

* Healthy adults aged of 18 years old or older.
* Non-smoking.

Exclusion Criteria:

* Diabetes or prediabetes
* Uncontrolled hypertension
* Uncontrolled thyroid function
* Taking medication that will affect lipid/glucose metabolism
* Severe infection or inflammation
* Pregnancy

Primary outcomes:
measure: Concentration of Total Plasma Ketones
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS)
state: Quebec
Study officials:
affiliation: Research Centre on Aging CSSS-IUGS - CIUSSS de l'Estrie - CHUS
name: Stephen Cunnane, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02777606: The Efficacy of Si-Ni-Tang (a Chinese Herbal Formula) for Severe Sepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Sepsis
Keywords: Severe Sepsis
Sini Decoction
Immune Function
Mortality
Lead sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2016-05-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
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 evaluate the efficacy of Si-Ni-Tang (a Chinese Herbal Formula documented in Shang Han Lun) in treating severe sepsis.


Eligibility criteria: Inclusion Criteria:

* Severe sepsis (according to American college of chest Physicians/ Society of Critical Care Medicine (ACCP/SCCM) criteria)
* Informed consent provided by patients or legally authorized representative
* Yin syndrome in syndrome differentiation (according to principles of traditional Chinese medicine (TCM) syndrome differentiation)

Exclusion Criteria:

* Pregnant or nursing female
* Subject receiving immunosuppressive or immunoenhancement therapy in the past 3 months
* Patients with known or suspicious autoimmune diseases
* Patients not expected to survive 28 days due to end-stage disease or other uncorrectable medical condition
* Fasting subjects
* Known or suspicious allergy to any ingredient of Si-Ni-Tang
* Patients not expected to survive 5 days for various reasons

Primary outcomes:
measure: 28-day all-cause mortality rates
timeFrame: 28 days after enrollment
Secondary outcomes:
measure: Human leukocyte antigen DR (HLA-DR) expression on cluster of differentiation (CD) 14 T lymphocytes
timeFrame: day 0 and 3after enrollment
measure: CD 4+/ CD 8+ ratio
timeFrame: day 0 and 3after enrollment
measure: procalcitonin (PCT)
timeFrame: day 0 and 3 after enrollment
measure: Sequential Organ Failure Assessment (SOFA) score
timeFrame: day 0 and 3 after enrollment
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Chinese Medicine
state: Guangdong
Study officials:
affiliation: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Fang Lai, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zeng R, Zheng Y, Fan R, Zhou G, Zhang Y, Mai S, Xie D, Weng Y, Du J, Han Y, Lai F. Si-ni-tang (a Chinese herbal formula) for improving immunofunction in sepsis: study protocol for a pilot randomized controlled trial. Trials. 2019 Aug 28;20(1):537. doi: 10.1186/s13063-019-3646-3.
Clinical trial NCT00004806: Phase I Study of Liposome-Mediated Gene Transfer in Patients With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cystic Fibrosis
Keywords: cardiovascular and respiratory diseases
cystic fibrosis
genetic diseases and dysmorphic syndromes
rare disease
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2000-02-25
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

Evaluate the efficacy and safety of lipid-mediated transfer of the cystic fibrosis transmembrane conductance regulator gene to nasal epithelium in patients with cystic fibrosis.

Detailed description: PROTOCOL OUTLINE: Cystic fibrosis transmembrane conductance regulator (CFTR) gene complexed with lipid is administered intranasally to the right inferior turbinate. Lipid without CFTR is administered to the left nostril as a control.

Cohorts of 3 patients are given successively lower doses of CFTR, each dose complexed with 500 micrograms of lipid.

Patients are followed at days 2-12, 15, and 21, then every 3-4 days for 3 weeks, every 2-3 weeks for 10 weeks, and every 3 months thereafter.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Cystic fibrosis (CF), i.e.: Sweat chloride greater than 60 mEq/L Clinical manifestations of CF Homozygous delta F508 mutation preferred Compound heterozygotes for F508 mutation with pancreatic insufficiency eligible FEV1 greater than 40% of predicted PO2 at least 60 mm Hg on room air No acute or recurrent sinusitis No obstructive nasal polyposis No pneumothorax or hemoptysis, e.g., more than 250 mL blood within 24-hour period, within past year No unstable lung disease with worsening pulmonary symptoms, arterial blood gas, or pulmonary function tests within 2 weeks prior to entry No pulmonary exacerbation within 4 weeks prior to entry --Prior/Concurrent Therapy-- At least 2 months since participation in any other clinical study At least 2 months since DNase At least 4 months since corticosteroids --Patient Characteristics-- Cardiac: No severe cardiac disease Other: No other severe organ system disease, e.g., juvenile-type diabetes mellitus No pregnant women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Alabama at Birmingham
name: Eric J. Sorscher
role: STUDY_CHAIR
References:
Clinical trial NCT03243006: Effect of Early Pain Management at Triage on Opioid Consumption
Official title: Effect of Early Analgesic Treatment on Opioid Consumption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Pain
Keywords: acute pain
emergency department
opioid consumption
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2017-08-08
Enrollment: 1500
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: SUPPORTIVE_CARE

Brief summary: introduction: Pain remains one of the most common reasons of emergency department admission. Opioids are overprescribed in emergency departments to treat severe pain.

objective: assessing the impact of ealy pain pain management on the use of intravenous morphine and on patient satisfaction.


Eligibility criteria: Inclusion Criteria:

* over 18 years of age
* a visual analog scale (VAS) equal to or higher than 30/100 ,
* having given consent to participation
* No contraindications to products used in the course of the study.

Exclusion Criteria:

* having a vital distress that does not allow an adequate assessment of the intensity of the pain
* an inability to assess pain intensity according to the VAS,
* swallowing disorders or inability , or a contraindication or an allergy to the treatments used.

Primary outcomes:
measure: use of rescue opioids
timeFrame: DURING emergency department stay
Secondary outcomes:
measure: patient satisfaction
timeFrame: When quitting emergency department
measure: Length of emergency department stay
timeFrame: Until emergency department discharge
measure: Pain intensity at emergency department discharge
timeFrame: At emergency department discharge
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02830906: Effect of Ramosetron in Prevention of Intrathecal Morphine Induced Nausea and Vomiting
Official title: Comparison of Ramosetron With Ondansetron for Prevention of Intrathecal Morphine Induced Nausea and Vomiting After Primary Total Knee Arthroplasty: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Nausea and Vomiting
Keywords: Total Knee Arthroplasty
Intrathecal Morphine
Ramosetron
Ondansetron
postoperative nausea and vomiting
Lead sponsor: Thammasat University
Sponsor class: OTHER
First posted: 2016-07-13
Enrollment: 99
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We would like to know the prophylactic anti-emetic effect of ramosetron compare to ondansetron in patient undergone total knee arthroplasty with spinal anesthesia and intrathecal morphine .

Detailed description: The patients were allocated into 2 groups by computerized block randomization according to a computer generated randomization. Treatment allocations were contained in sealed envelopes that were opened after patient enrollment. Patients received either 8 mg of intravenous (IV) ondansetron or 0.3 mg of IV ramosetron 10 minutes before spinal anesthesia and intrathecal morphine. All of the unilateral TKAs were done by one orthopedic surgeon using the same minimally invasive surgical technique and the same prosthesis.

Patients were monitored for incidence of Post Operative Nausea Vomiting(PONV) every 6 hours until 24 hours, and 24-48 hours postoperatively. Common adverse drug reactions associated with serotonin receptor antagonists (pruritus, dizziness, and headache) were also recorded.

The sample size calculation was based on the ability to detect a difference in incidence of postoperative nausea in between the two groups of 40% i.e. 50% in the ondansetron arm, and 30% in the ramosetron arm, consistent with a previous study. Using a power of 80% (β=0.2) and a two sided significance level(alpha) of 0.05, 45 patients in each group were required.

Eligibility criteria: Inclusion Criteria:

* Patients aged 50-80 years with a diagnosis of primary OA undergoing unilateral TKA
* American Society of Anesthesiologist (ASA) physical status I-III
* Giving written informed consent

Exclusion Criteria:

* Body mass index (BMI) \> 35 kg/m2
* Unable to undergo spinal anesthesia
* History of allergic to study drugs
* Impaired renal and/or hepatic function
* Use of systemic steroids and anti-emetics within 24 hours of operation

Primary outcomes:
measure: Incidence rate of postoperative nausea and vomiting
timeFrame: 48 hours after the operation
Secondary outcomes:
measure: number of patients require for anti-emetic medicine
timeFrame: 48 hours after the operation
measure: visual analog scale for pain
timeFrame: 48 hours after operation
Other outcomes:
Locations:
Study officials:
affiliation: Thammasat University
name: piya pinsornsak, md
role: PRINCIPAL_INVESTIGATOR
References: