louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01283568: Safety and Efficacy Study of Gamaline+Hipericin in PMS
Official title: Phase IV Study of Combined GAMALINE and HIPERICIN for Treating Pre-Menstrual Syndrome and Vasomotor Symptoms
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Edema
Depression
Hot Flashes
Anxiety
Irritability
Keywords: PMS, climacteric, depression
Lead sponsor: Phytopharm Consulting Brazil
Sponsor class: NETWORK
Collaborators: name: Herbarium Laboratorio Botanico Ltda
name: Federal University of Health Science of Porto Alegre
First posted: 2011-01-26
Enrollment: 240
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Only women from 25 to 55 years old with PMS symptoms

Brief summary: GAMALINE is already register for PMS and HIPERICIN as antidepressive drug. Both plant extracts. The investigators will try the mixture and see if the vasomotor symptoms will disappear. The investigators expect that together all symptoms will be covered better than Gamaline alone. The investigators will run for 180 days measuring at T0, T1 and T6 (starting point, 30 days and 180 days).

Detailed description: This protocol wants to show the advantages for the mixture GAMALINE 900mg+HIPERICIN 300mg - 2 herbal extracts for PMS treatment against the individual use of GAMALINE

Eligibility criteria: Inclusion Criteria:

* climacteric pre-menopausal women between 45 e 55 anos
* women between 25 e 44 anos

Exclusion Criteria:

* Age inferior 25 anos or superior 55 anos and/or decline invitation.
* Patients pos-menopause
* Under hormone therapy
* Thyroid disease
* Under psychiatric therapy or medication
* History for allergies and hypersensitivity to one or both extracts
* Breast feeding or pregnancy
* No knowledge for writing and/or reading

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Ambulatório de Ginecologia e Obstetrícia ISCMPA
state: RS
Study officials:
affiliation: Phytopharm Consulting Brazil - karla@phytopharm.com.br
name: Karla F Deud José, Pharm PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01344668: The Public Private Partnership Addressing Literacy-Numeracy to Improve Diabetes Care
Official title: The Public Private Partnership Addressing Literacy-Numeracy to Improve Diabetes Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Diabetes
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2011-04-29
Enrollment: 411
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The primary hypotheses are that the intervention will improve A1C, blood pressure, lipids, weight, self-efficacy, self-management behaviors, and use of clinical services at 12 and 24 months follow-up.


Eligibility criteria: Inclusion Criteria:

* Patient has a clinical diagnosis of Type 2 Diabetes
* Age 18-85 years
* English or Spanish speaking
* Most recent A1C ≥ 7.5%
* Patient agrees to participate in the study for the full two years duration.

Exclusion Criteria:

* Poor visual acuity (vision worse than 20/50 using Rosenbaum Pocket Screener) -- Significant dementia or psychosis (by health provider report or chart review)
* Terminal illness with anticipated life expectancy \< 2 years (per health provider or patient report).

Primary outcomes:
measure: Improvement in A1C at 12 months
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Russell L. Rothman, MD, MPP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01409668: Efficacy of Two Yogurt Formulations in Healthy Humans
Official title: Efficacy of Two Yogurt Formulations as Health Promoting Agents in Healthy Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Micropharma Limited
First posted: 2011-08-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the safety and efficacy of consumption of: L.Ruteri containing yogurt, L.Fermentum containing yogurt VERSUS placebo on plasma lipids, as well as gastrointestinal microflora distribution in hyperlipidemic individuals.


Eligibility criteria: Inclusion Criteria:

* Healthy males and females
* aged 18-60 yr
* plasma LDL-C 130-260 mg/dl
* TG levels below 400 mg/dl
* body mass index (BMI) rangewill be 22 to 32 kg/m2
* permitted to take stable doses of thyroid hormone and anti hypertensive agents, as long as these are continued equivalently throughout the duration of study

Exclusion Criteria:

* history of recent (i.e. less than 3 mo) or chronic use of oral hypolipidemic therapy, including fish oils, or probucol within the last 6 mo, - history of chronic use of alcohol (\>2 drinks/d), systemic antibodies, corticosteroids, androgens, or phenytoin,
* myocardial infarction, coronary artery bypass, or other major surgical procedures within the last six months
* recent onset of angina, congestive heart failure, inflammatory bowel disease, pancreatitis, diabetes, lactose intolerance or significant current (ie. onset within past three months) gastrointestinal, renal, pulmonary, hepatic or biliary disease, or cancer (evidence of active lesions, chemotherapy or surgery in the past year
* chronic user of probiotics, fiber laxative (greater than 2 doses/wk), or stimulant laxatives or has a history of eating disorders, exercise greater than 15 miles/wk or 4,000 kcal/wk.

Primary outcomes:
measure: Cholesterol Metabolism
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06800768: The Value of 68Ga-FAPI PET/CT in Detecting Recurrent and Metastatic Lesions in Patients with Thyroid Cancer After Surgery
Official title: The Value of 68Ga-FAPI PET/CT in Detecting Recurrent and Metastatic Lesions in Patients with Thyroid Cancer After Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thyroid Cancer
Keywords: Thyroid Cancer
68Ga-FAPI
PET/CT
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2025-01-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients and outpatients at Ruijin Hospital who meet the inclusion criteria.

Brief summary: This study aims to investigate the value of 68Ga-FAPI PET/CT in detecting recurrent and metastatic lesions in patients with thyroid cancer after surgery.

Detailed description: The investigators will number all participants, create a medical record file, and record their basic information (gender, age) as well as contact information and medical history information. All participants will undergo a 68Ga-FAPI PET/CT when recurrence or metastasis is suspected. The imaging response measurements will be compared with follow-up results or histopathological findings as the gold standard.

Eligibility criteria: Inclusion Criteria:

1. Patients with thyroid cancer who have undergone surgery and are suspected of recurrence or metastasis during clinical evaluation.
2. Signed and dated informed consent form.
3. Commitment to comply with research procedures and co-operation in the implementation of the full research process.
4. Aged 18-80 years old.

Exclusion Criteria:

1. Patients with serious illnesses that researchers consider unsuitable for participation in this clinical study. Such as severe heart and lung failure, severe bone marrow suppression, severe liver and kidney dysfunction, etc.
2. Intestinal perforation, complete intestinal obstruction.
3. Pregnant women and women who may be pregnant, women who are breastfeeding.
4. Non-compliant person.

Primary outcomes:
measure: Diagnosis of recurrent or metastatic thyroid cancer
timeFrame: Within 1 week after enrollment
Secondary outcomes:
measure: Standardized uptake value(SUV)
timeFrame: Within 1 week after enrollment
measure: Disease free survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine
state: Shanghai
Study officials:
References:
Clinical trial NCT02174068: A Pharmacokinetic Drug Interaction and Tolerance Study of Paracetamol and Nefopam
Official title: A Pharmacokinetic Drug Interaction and Tolerance Study of Paracetamol and Nefopam
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Paracetamol
Nefopam
Pharmacokinetic
Drug interaction
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2014-06-25
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Pain remains the leading cause of consultation. Despite a wide therapeutic arsenal, a significant percentage of patients disclaim little or no pain relief with common analgesics, specific or not their type of pain. This is especially true in cases of chronic pain, and current treatments are associated with many side effects. A need for therapeutic innovation is needed. Paracetamol is currently the most widely used analgesic worldwide but despite its excellent safety, its analgesic effect is limited from moderate to severe pain. Many analgesic drug combinations include paracetamol, recently the co-administration of paracetamol and nefopam showed a supra-additive antinociceptive effect (Van Elstraete AC et al. 2013). The development of a formulation associating paracetamol and nefopam first requires searching a possible pharmacokinetic interaction between the two active substances and assessing safety of this combination in healthy volunteers. No published studies providing such information.

Detailed description: This is a randomised, cross-over, open label trial assessing drug interaction between paracetamol and nefopam in healthy volunteers.

Eligibility criteria: Inclusion Criteria:

* Age over 18
* ALT, AST, PAL, normal GGT, creatinine \<133μmol / L, hematocrit\>38%
* Informed consent to the trial
* Healthy volunteers affiliated to the French Social Security

Primary outcomes:
measure: Existence of drug interaction
timeFrame: AT DAY 1
Secondary outcomes:
measure: influence of paracetamol on the kinetics of nefopam
timeFrame: AT DAY 1
measure: Measure of plasma pharmacokinetic parameters of each active metabolites and principles (dosage nefopam, N-desmethyl-nefopam, paracetamol, paracetamol glucuronide, paracetamol sulfate) alone
timeFrame: at day 1
measure: Measure of plasma pharmacokinetic parameters in combination (AUC, Cmax, Tmax, half-life time of apparent elimination terminal).
timeFrame: at day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Claude DUBRAY
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05279768: Stem Cells and Secretomes for Infertility Therapy in Polycystic Ovary Syndrome (PCOS) Patients With Insulin Resistance.
Official title: Potential Use of Umbilical Cord Mesenchymal Stem Cells and Secretoms for Infertility Therapy in Polycystic Ovary Syndrome (PCOS) Patients With Insulin Resistance.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Polycystic Ovary Syndrome
Keywords: Umbilical Cord Mesenchymal Stem Cell
Secretome
Lead sponsor: PT. Prodia Stem Cell Indonesia
Sponsor class: INDUSTRY
First posted: 2022-03-15
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigating the effect of Umbilical Cord Mesenchymal Stem Cell (UC-MSCs) and secretomes to insulin resistance in Polycystic Ovary Syndrome (PCOS) patients. This study has 4 arms namely UC-MSCs treatment, secretomes treatment, UC-MSCs and secretomes treatment, and control.

Detailed description: The investigator hypothesized that PCOS patients with insulin resistance given combination of UC-MSCs and secretomes can improve their clinical and laboratory insulin resistance, haid ovulatory cycle and fertility. All group will be observed every 1,3, and 6 months after injection.

Eligibility criteria: Inclusion Criteria:

* PCOS patients with insulin resistance based on Rotterdam Consensus criteria, i.e. menstrual disorders (oligomenorhea/ amennorhea)
* Patients must have hiperandrogenemia clinical and laboratory proof (Ferriman Gallwey score \>8)
* Patients with Free Androgen Index (FAI) \>4 and ovary polycystic from USG transvaginal
* Patients with Homeostatic (HOMA) IR score ≥ 1.7

Exclusion Criteria:

* Patients who are allergic to component of WJ-MSC or Secretome.
* Patients who are not currently on hormon treatment of other resistance treatment.
* Refusing or not participating in part / all of the research process.
* Patients with positive diagnosis of hepatitis A,B,C, and HIV

Primary outcomes:
measure: Blood serum sample
timeFrame: Follicular phase on day 10-12
measure: Free Androgen index (FAI)
timeFrame: Follicular phase on day 10-12
measure: Insulin, Glucose Plasma, and Insulin Resistance
timeFrame: Follicular phase on day 10-12
measure: Sex Hormone Binding Globulin (SHBG) and Anti-Mullerian Hormone (AMH)
timeFrame: Follicular phase on day 10-12, and 1,3,6 months after stem cells
measure: Leptin and Adiponectine Profile
timeFrame: 1,3,6 months after stem cells
measure: TNFα, IL-1 β, IL-6, IL-10 Profile
timeFrame: 1,3,6 months after stem cells
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: PT Prodia StemCell Indonesia
Study officials:
affiliation: Prodia Stem Cell Indonesia
name: Rima Haifa, B.Sc
role: STUDY_CHAIR
References:
Clinical trial NCT03561272: The Validation of a Novel Adherence Method for Oral Oncolytics
Official title: The Validation of a Novel Adherence Method for Oral Oncolytics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2018-06-19
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The long-term goal of this research is to apply technologic approaches to improve the use of oral oncolytics. The objective of this study is to assess patient adherence to oral oncolytics and to validate a currently available smart phone application (iRxReminder) partnered with an automated dispensing device, a "Pod", in affecting patient adherence. The rationale for this study is that medication adherence to oncolytics varies and strategies are needed to improve it.


Eligibility criteria: Inclusion Criteria:

* Must be \> 18 years of age
* Must have a smart phone
* Must be able to have their oral oncolytic filled at the University of Michigan Comprehensive Cancer Center pharmacy and be newly prescribed Capecitabine (Xeloda).

Exclusion Criteria:

* Patients who do not have a smart phone
* Patients who have a serious mental illness or cognitive impairment, e.g., psychosis or dementia.
* Patients who do not speak English
* Patients who cannot fill their oral oncolytic prescription at the University of Michigan Comprehensive Cancer Center Pharmacy

Primary outcomes:
measure: The change in the number of patients that report high adherence over time via smart phone application alone
timeFrame: 0, 4, 8 and 12 weeks
measure: The change in the number of patients that report high adherence over time via smart phone application and POD
timeFrame: 0, 4, 8 and 12 weeks
measure: The change in the number of patients that report high adherence over time via telephone/face-to-face visit (self-reported)
timeFrame: 0, 4, 8 and 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: The University of Michigan Comprehensive Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Shawna Kraft, Pharm.D., BCOP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00371072: Trabeculectomy With MMC Versus Ahmed Glaucoma Implant for Treatment of Pediatric Aphakic Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pediatric Aphakic Glaucoma
Keywords: Aphakic Glaucoma
trabeculectomy with mitomycin- C
Ahmed glaucoma implant
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2006-09-01
Sex: ALL
Minimum age (years): 0
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this randomized clinical trial we compare trabeculectomy with mitomycin-C (T+MMC) and Ahmed glaucoma implant (AGI) in treatment of aphakic glaucoma in children under 16 years of age.Complete and qualified success were defined as 5≤IOP≤21mmHg without and with medication respectively and we came to this point that; T+MMC and AGI are comparable in terms of success rate and complications in pediatric aphakic glaucoma.


Eligibility criteria: Inclusion Criteria:

* congenital cataract
* history of cataract surgery
* under 16 years old
* Ocular pressure more than 21 mmHg

Exclusion Criteria:

* interruption of the follow up before 6 month
* Anterior segment dysgenesis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Ophthalmic Research Center
Study officials:
affiliation: Ophthalmic Research Center of Shaheed Beheshti Medical University
name: Mohammad Pakravan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06969872: Effects of Probiotics on Symptoms of Constipation in Adults With Functional Constipation
Official title: The Effects of ABKefir on Functional Constipation in Subjects: a Randomized, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Functional Constipation (FC)
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
Collaborators: name: SYNBIO TECH INC. Kaohsiung Taiwan
First posted: 2025-05-14
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to evaluate the efficacy of 1 capsules of ABKefir per day on symptoms of constipation in subjects with functional constipation by clinical trial.

Detailed description: This randomized, placebo-controlled clinical trial will be conduct for 8 weeks with one hundred and sixty-five adults. Subjects will be recruited and randomly assigned into three groups: (1) placebo, n = 55; (2) low dose of ABKefir , n = 55; (3) high dose of ABKefir, n = 55. During the first 4 weeks of supplement, the subjects should take one capsule of placebo or ABKefir daily. Apart from containing no probiotics, the content of placebo is same as ABKefir. After that, the next 4 weeks is to have a follow-up of subjects. During this phase, subjects don't need to supplement. Subjects should complete the assessment of anthropometric measurement, defecation questionnaire , food record, feces and blood collection at week 0, 4 and week 8.

Eligibility criteria: Inclusion Criteria:

* male or female
* aged 18-75 years old
* fulfill Rome IV criteria for functional constipation
* have not participated in similar research in the past three months

Exclusion Criteria:

* Personal or family history of colon cancer, celiac disease, and inflammatory bowel disease
* Irritable bowel syndrome diagnosed during colonoscopy
* Those who are pregnant recently (including men and women), or are pregnant or breastfeeding women.
* Taking antidepressants, anti-anxiety drugs and other psychotropic drugs.
* Long-term medication is required to improve constipation
* Those diagnosed with myocardial infarction, cerebral infarction, malignant tumor and/or other serious diseases are not suitable for participating in the study.
* Allergic symptoms to probiotics or any ingredients
* Having a history of serious mental illness
* Drug-related crimes or alcohol problems
* Have recently traveled to areas where parasitic diseases are prevalent.

Primary outcomes:
measure: Change from baseline symptoms of constipation at week 4 and 8
timeFrame: Week 0, 4 and 8
measure: Change from baseline symptoms of constipation at week 4 and 8
timeFrame: Week 0, 4 and 8
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University
state: South
Study officials:
affiliation: Chung Shan Medical University
name: Hsin-Chi Pan, MS student
role: PRINCIPAL_INVESTIGATOR
References: