louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05066048: Intestinal Microecological Dysregulation Caused by Appendectomy Increases the Risk of Colorectal Cancer
Official title: Intestinal Microecological Dysregulation Caused by Appendectomy Increases the Risk of Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Neoplasms
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2021-10-04
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with an appendectomy and meet the above conditions

Brief summary: As a good niche for bacterial growth, appendix plays a very important role in maintaining and protecting intestinal symbiotic flora. Appendectomy will lead to intestinal microecological disorders. Therefore, we put forward the hypothesis that "appendectomy leads to intestinal microecological disorders and then increases the risk of colorectal cancer". In this study, the feces of normal controls, appendectomy and patients with colorectal cancer were collected, and the specific changes of intestinal flora after appendectomy were explored in detail from the level of family, genus and species by macrogenomic sequencing. Then through functional gene analysis, metabolic pathway analysis and other methods to explore the molecular mechanism of colorectal cancer risk changes and the changes of microflora involved, and verified by mouse fecal bacteria transplantation animal experiment.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing appendectomy due to appendicitis;
* 6-36 months after appendectomy;
* Patients with no obvious abnormality observed by colonoscopy;
* Age between 20 and 85.

Exclusion Criteria:

* A. Any history of malignancy or disease
* Any inflammatory bowel disease (IBD) prior to study inclusion;
* Antibiotics and hormone drugs taken within the last three months;
* Patients with severe systemic diseases (severe diabetes, hypertension or autoimmune diseases, etc.);
* Severe clinical symptoms of digestive tract (severe diarrhea, constipation, purulent disease, etc.) within half a year.

Primary outcomes:
measure: Species composition of fecal microbial
timeFrame: 1 year
Secondary outcomes:
measure: weight in kilograms
timeFrame: baseline, pre-procedure
measure: height in meters
timeFrame: baseline, pre-procedure
measure: age in year
timeFrame: baseline, pre-procedure
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiao Tong University
state: Shaanxi
Study officials:
References:
Clinical trial NCT04744948: Effect Of Treadmill Based Aerobic Exercise Intervention On Menstruation And Quality Of Life In Women With Polycystic Ovarian Syndrome
Official title: Effect Of Treadmill Based Aerobic Exercise Intervention On Menstruation And Quality Of Life In Women With Polycystic Ovarian Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polycystic Ovary Syndrome
Irregular Menses
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-02-09
Enrollment: 60
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 28
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: control group receive low caloric diet study group receive high intensity interval training
Primary purpose: TREATMENT

Brief summary: this study will be carried to investigate the effect of aerobic exercise on menstrual regularity and quality of life in pco women

Detailed description: This study will be carried out on sixty females with polycystic ovarian syndrome (PCOS) patients will be randomly assigned into two equal groups: control group (30 women) will receive low caloric diet 1200 Cal/day) while study group (30 women) will receive the same diet regime and treadmill aeobic exercise

Eligibility criteria: Inclusion Criteria:

* women with pco
* age from17 to 28 years
* BMI 25- 30

Exclusion Criteria:

* Asthma and chronic respiratory disease
* congenital spinal problems
* cardiopulmonary disease
* physical impairments

Primary outcomes:
measure: menstrual regularity
timeFrame: 3 months
measure: quality of life questionnaire (QOLQ)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: fahema m okiel, phd
role: STUDY_DIRECTOR
affiliation: Cairo University
name: amal mo youssef, phd
role: STUDY_CHAIR
References:
Clinical trial NCT02950948: Progesterone in Luteal Phase Deficiency
Official title: Prospective, Randomised, Double-blind, Placebo Controlled, Phase III Clinical Study Assessing the Efficacy of 25 mg Natural Progesterone Administered Subcutaneously in Restoring the Normal Luteal Phase in Women With Previous Diagnosis of Luteal Phase Deficiency
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Luteal Phase Defect
Lead sponsor: IBSA Institut Biochimique SA
Sponsor class: INDUSTRY
First posted: 2016-11-01
Enrollment: 0
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of this study will be to assess the efficacy of natural progesterone at a daily dose of 25 mg in restoring a normal luteal phase. The primary end-point will be the ongoing pregnancy rate.

The secondary objectives will be the rate of endometrial biopsy showing an in phase endometrium after 3 months of treatment.

The length of the luteal phase of the menstrual cycle after treatment will also be assessed and compared with the initial duration (from LH peak to onset of menstruation).


Eligibility criteria: Inclusion Criteria:

* Women who wish to get pregnant with a previous diagnosis of luteal phase deficiency:
* Able and willing to sign the Subject Consent Form and adhere to the study visit schedule;
* Age: 20-35 years;
* BMI: 18-28 kg/m2;
* Inadequate luteal phase (menstrual period shorter than 21 days);
* Sub-fertile couple: 12 months of trying to conceive without success.
* Normal uterine cavity;
* Basal P4 level (day 3 of a previous cycle) ≤ 3ng/ml;
* Non-smoking;
* Fertile male partner (normal sperm count).

Exclusion Criteria:

* History of recurrent miscarriage;
* Basal P4 level (day 3 of a previous cycle) \> 3ng/ml;
* Severe uterine malformations (including submucosal fibroids, endometrial polyps, and intrauterine adhesions) ;
* Known hypersensitivity to study medication;
* Neoplasias (known or suspected breast or genital tract cancer);
* Severe impairment of hepatic or renal function;
* Use of concomitant medications that might interfere with study evaluations (other hormonal treatment);
* Current vaginal infection;
* Endometriosis;
* PCOS;
* Partially or completed block of fallopian tubes;
* Hydrosalpinx;
* Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events;
* Porphyria;
* A history of idiopathic jaundice, severe pruritus or pemphigoid gestationis during pregnancy;
* Antiphospholipid syndrome;
* Diabetes mellitus;
* Thyroid diseases or autoimmune conditions;
* Hypothalamic dysfunction;
* Hyperprolactinaemia;
* Infertility due to male factor;
* Smokers.

Primary outcomes:
measure: Ongoing pregnancy rate at 12 weeks of gestation
timeFrame: 12 weeks
Secondary outcomes:
measure: Rate of in phase endometrial biopsies
timeFrame: 3 months
measure: Length of luteal phase
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04006548: To Explore the Influence of Appetite Reduction and Medication Effect of Methylphenidate in Patients With Attention-deficit/Hyperactivity Disorder(ADHD) Through Pharmacogenetics.
Official title: To Explore the Influence of Appetite Reduction and Medication Effect of Methylphenidate in Patients With Attention-deficit/Hyperactivity Disorder Through Pharmacogenetics.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Methylphenidate Adverse Reaction
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 110
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adolescents aged between 6 to 17 years old, diagnosed as ADHD, and recieved methylphenidate treatment.

Brief summary: We plan to recruit 200 children and adolescents aged between 6 to 17 years old in two years. Those patients would receive clinical interview by child psychiatrists to diagnose as ADHD and to exclude mental retardation, major psychiatric disorders and medical disorders. Moreover, we excluded children who ever received ADHD medication treatment more than one year, or received medication in recent 30 days. Initial assessment includes collecting saliva sample, and complete questionnaires (SNAP-IV), clinical rating (CGI-S) and psychological test (CPT-II, WISC-IV, CANTAB). After 1 month methylphenidate treatment, we would evaluate SNAP-IV, CGI-S, CGI-I and Barkley Psychostimulants Side Effects Rating Scale. We also would collect saliva samples to perform appetite related gene phenotyping to see the association between medication side effect and polymorphism of appetite related genes.


Eligibility criteria: Inclusion Criteria:

* Age range from 6 years old to17 years old
* Diagnosis of ADHD.

Exclusion Criteria:

* mental retardation.
* major psychiatric disorders
* major medical disorders.

Primary outcomes:
measure: Barkley psychostimulants side effect scale
timeFrame: One month methylphenidate use
measure: Clinical Global Impression scale-Improvement (CGI-I)
timeFrame: One month methylphenidate use
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
Study officials:
References:
Clinical trial NCT00793026: Dermacyd Breeze Pocket BR (Lactic Acid) - Acceptability
Official title: Safety Dermatological Evaluation: Genital Mucous Irritation - Test in Use - Dermacyd Breeze Pocket BR (Lactic Acid).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-11-18
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to prove the safety of the gynaecological formulation in normal conditions of use.


Eligibility criteria: Inclusion criteria:

* Integral skin test in the region;
* To use products of the same category;

Exclusion criteria:

* Lactation or gestation;
* Use of anti-inflammatory, anti-histaminic or immunosuppressant drugs;
* Cutaneous disease (local or spread) in the evaluation area;
* Pathology which may cause immunity depression, such as HIV, diabetes;
* Endocrine pathology
* Solar exposure 15 days before evaluation;
* Treatment until four months before the selection.
* Allergic or atopic history to cosmetics products

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Absence of irritation
timeFrame: Throughout the study
measure: Good acceptability
timeFrame: Throughout the study
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Jaderson Lima
role: STUDY_DIRECTOR
References:
Clinical trial NCT03201926: Development and Clinical Application of Invalid Foods Using Mealworms
Official title: Development and Clinical Application of Invalid Foods Using Mealworms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatobiliary Disease; Liver Disease
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2017-06-28
Enrollment: 168
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Malnutrition in cancer patients continues after surgery and worsens the patient's overall health and quality of life. Previous studies reported edible insects in patients' diets increased postoperative muscle mass and weight gain. Therefore, by using nutritionally excellent mealworms for a long time, it is proved that nutritional status and survival rate are improved, leading to development of various products of edible insects.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for surgery with pancreaticobiliary disease and liver cancer (metastatic liver cancer)
* Karnofsky performance status ≥ 70
* Patients who can communicate without difficulty in obtaining a consent form for the test

Exclusion Criteria: Patients with any of the following criteria are excluded.

* Patients who underwent palliative surgery
* Patients with uncontrolled pre-operative disease
* Previous history of surgery affecting nutritional status
* Pregnant and lactating women
* Patients with allergy to mealworms

Primary outcomes:
measure: Improvement of Body mass index
timeFrame: Changes from baseline nutition index at Preoperative 1 day, Postoperative 14 days (one week after take mealworms), Postoperative 2 months( two months after take mealworms)
Secondary outcomes:
measure: Improvement of Body weight change
timeFrame: Changes from baseline Body weight at Preoperative 1 day, Postoperative 14 days (one week after take mealworms), Postoperative 2 months( two months after take mealworms)
measure: Improvement of Immune Function Index
timeFrame: Changes from baseline nutition index at Preoperative 1 day, Postoperative 14 days (one week after take mealworms), Postoperative 2 months( two months after take mealworms)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
Study officials:
References:
citation: Kim HS, Lee YS, Jang SY, Jun SY, Lim JH, Kim IK, Kim HM, Park JS. Clinical application of invalid foods using mealworms and evaluation of nutrition status and immune function: a study protocol for a randomized, double blind, placebo-controlled trial. BMC Nutr. 2019 Nov 18;5:44. doi: 10.1186/s40795-019-0307-6. eCollection 2019.
Clinical trial NCT04430426: Heterozygous Individuals for AGXT and Kidney Stones
Official title: Heterozygous Individuals for AGXT and Kidney Stones
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Kidney Stone
Keywords: kidney stone
oxalate
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2020-06-12
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study seeks to examine the effects of a heterozygous mutation of the AGXT gene in a stone forming population on endogenous oxalate production. Participants will consume a controlled low-oxalate diet and provide blood and urine samples to measure the amount of oxalate in their bodies. Subjects will then be administered an intravenous (IV) load of glycolate, providing additional blood and urine samples afterwards to measure any increase in oxalate levels.


Eligibility criteria: Inclusion Criteria:

* at least 18 years of age
* history of calcium oxalate stones
* heterozygous mutation of the AGXT gene, as evidenced by results from the Invitae Nephrolithiasis Panel
* willingness to comply with a controlled diet for five days

Exclusion Criteria:

* pregnant individuals
* individuals who are currently breast feeding

Primary outcomes:
measure: Urinary Oxalate Excretion
timeFrame: Baseline through Day 6
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Alabama at Birmingham
name: Kyle Wood, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06041126: The Effect of Clinical Parameters on Muscle Oxygenation in Patients With COPD
Official title: The Effect of Disease Severity and Respiratory Functions on Muscle Oxygenation in Stable COPD Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Muscle Oxygenation
Disease Severity
Respiratory Function
Keywords: Chronic Obstructive Pulmonary Disease
Muscle Oxygenation
Disease Severity
Respiratory Function
Lead sponsor: Bandırma Onyedi Eylül University
Sponsor class: OTHER
First posted: 2023-09-18
Enrollment: 41
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Stable COPD Patients

Brief summary: The aim of this study is to examine the peripheral muscle oxygenation of patients with Chronic Obstructive Pulmonary Disease at rest, during submaximal exercise and recovery, and to examine the effects of disease severity and respiratory functions on peripheral muscle oxygenations. In this study, the effect of disease severity and respiratory problems on peripheral muscle metabolism of patients with COPD will be explained.


Eligibility criteria: Inclusion Criteria:

* Being diagnosed with COPD (according to GOLD Staging: GOLD 1, GOLD 2, GOLD 3, GOLD 4)
* Being between the ages of 40-80
* Body Mass Index \<35
* Not having an acute exacerbation in the last 3 months

Exclusion Criteria:

* Patients who do not want to participate in the study
* Arthritis causing weakness in the lower extremity, neurological disease, deep vein thrombosis, peripheral arterial disease, muscle weakness, fracture etc. patients with the condition
* Common diseases such as malignancy, pulmonary embolism, vasculitis, collagen tissue diseases, interstitial fibrosis, severe pneumonia patients with parenchymal destruction
* Patients with severe dyspnea and hemodynamic instability who cannot perform the 6 Minute Walk Test

Primary outcomes:
measure: Muscle oxygenation
timeFrame: one day
Secondary outcomes:
measure: Modified Medical Research Council Dyspnea Scale
timeFrame: one day
measure: COPD Assessment Test (CAT)
timeFrame: one day
measure: Charlson Comorbidity Index
timeFrame: one day
measure: Quadriceps muscle strength measurement
timeFrame: one day
measure: Six-minute walking test
timeFrame: one day
measure: Pulmonary Function Test
timeFrame: one day
measure: Maximum Inspiratory Pressure / Maximum Expiratory Pressure Measurement
timeFrame: one day
Other outcomes:
Locations:
city: Balıkesir
country: Turkey
facility: Bandırma Onyedi Eylül University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Study officials:
References:
Clinical trial NCT01271426: Response to Ranibizumab in Polypoidal Choroidal Vasculopathy (PCV)and SNPs
Official title: Association of Complement Factor H and ARMS2 Genotypes With Response of Polypoidal Choroidal Vasculopathy to Intravitreal Ranibizumab
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polypoidal Choroidal Vasculopathy
Keywords: Polypoidal Choroidal Vasculopathy
Ranibizumab
Lead sponsor: Nihon University
Sponsor class: OTHER
First posted: 2011-01-06
Enrollment: 74
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: outpatients in hospital

Brief summary: To determine whether complement factor H (CFH) and age-related maculopathy susceptibility 2 (ARMS2) genotypes have a pharmacogenetic effect on the treatment of polypoidal choroidal vasculopathy (PCV) with ranibizumab.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Polypoidal choroidal vasculopathy
* must have injection of Ranibizumab

Exclusion Criteria:

-

Primary outcomes:
measure: Association of Complement Factor H and ARMS2 Genotypes with Response of Polypoidal Choroidal Vasuculopathy to Intravitral Ranibizumab
timeFrame: a month after injection
Secondary outcomes:
Other outcomes:
Locations:
city: 1-8-13 Kandasurugadai Chiyoda-ku
country: Japan
facility: Surugadai Nihon university hospital
state: Tokyo
Study officials:
References:
Clinical trial NCT01456026: Effects of Food Advanced Glycation Endproducts on Vascular Function in Diabetes
Official title: Acute Effects of Food Advanced Glycation Endproducts on Macrovascular Function in Subjects With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes
Advanced glycation endproducts
Endothelium
Lead sponsor: Profil Institut für Stoffwechselforschung GmbH
Sponsor class: INDUSTRY
Collaborators: name: Heart and Diabetes Center North-Rhine Westfalia
name: Icahn School of Medicine at Mount Sinai
First posted: 2011-10-20
Enrollment: 19
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Recent evidence supports detrimental effects of advanced glycation endproducts (AGE) on vascular function (VF). Though, the effect of AGE-modified proteins alone on vascular function remained unknown. Therefore, the aim of our study is to investigate the effects of heat-treated, glycated beta-lactoglobulins (BLG) on vascular function in subjects with type 2 diabetes mellitus (T2DM) and to compare it to non-glycated, heat-treated BLG.

Detailed description: In a double-blind, controlled, randomized, cross-over manner, 19 subjects with T2DM will receive on 2 different days beverages containing either glycated, heat-treated BLG or non-glycated, heat-treated BLG.

Macrovascular (brachial ultrasound of flow mediated dilatation -FMD) and microvascular function (laser-doppler measurements of reactive hyperemia at the hand) at baseline (T0), as well as 90 (T90) and 180 (T180) minutes after each beverage will be measured.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus

Exclusion Criteria:

* Other types of diabetes
* Major cardiovascular complications within 6 months prior to screening
* Major diabetes complications
* Failure to give informed consent

Primary outcomes:
measure: Postprandial Change from Baseline in Flow Mediated Dilatation
timeFrame: Baseline, 90 and 180 min after oral intake of food AGE
Secondary outcomes:
measure: Postprandial Change from Baseline in Microcirculation (Laser-Doppler measurements of reactive hyperemia at the hand)
timeFrame: Baseline, 90 and 180 min. following food AGE intake.
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Heart and Diabetes Center North-Rhine Westfalia
state: NRW
Study officials:
affiliation: Profil Institute for Metabolic Research GmbH
name: Alin O Stirban, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stirban A, Kotsi P, Franke K, Strijowski U, Cai W, Gotting C, Tschoepe D. Acute macrovascular dysfunction in patients with type 2 diabetes induced by ingestion of advanced glycated beta-lactoglobulins. Diabetes Care. 2013 May;36(5):1278-82. doi: 10.2337/dc12-1489. Epub 2012 Dec 13.