louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05265572: Evaluation of the Impact of a Personal and Domestic Hygiene Intervention on Lead Exposure in a Community Close to a Mine Dump
Official title: Evaluation of the Impact of a Personal and Domestic Hygiene Intervention on Lead Exposure in a Community Close to a Mine Dump
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lead Poisoning
Lead Poison Children
Keywords: Lead
Lead exposure
Mine Dumps
Lead sponsor: University of Johannesburg
Sponsor class: OTHER
Collaborators: name: Medical Research Council, South Africa
First posted: 2022-03-03
Enrollment: 576
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are divided into two groups and one group is assigned to one household hygiene and an educational intervention which they apply and the impact of the intervention on lead exposure is assessed and the other group has no intervention.
Primary purpose: PREVENTION

Brief summary: The study evaluates the impact of a personal and domestic hygiene intervention on exposure to lead in a community close to a mine dump. A before and after intervention study will be conducted in a selected area to determine lead exposure levels and the reduction or not after application of the intervention.

Detailed description: A before and after intervention study will be conducted with a control and intervention group, where data will be collected at the household (through questionnaire based interviews, floor and/or windowsill samples and soil samples collection) and individual level (through hand dust wipe sample collection). In phase one, both the control and intervention group will be interviewed, household floor and/or windowsill dust wipes will be taken, yard soil sample collected and hand dust wipe samples will be taken from children in participating households. After baseline data collection, participants will be allocated into either intervention or control group. The intervention group will participate in the domestic hygiene demonstration and educational discussion.

Eligibility criteria: Inclusion Criteria:

* Children between the ages of one and five years

Exclusion Criteria:

* Children above 5 years

Primary outcomes:
measure: Lead exposure level
timeFrame: Three months
Secondary outcomes:
measure: Reference Lead exposure level
timeFrame: Three months
Other outcomes:
Locations:
city: Johannesburg
country: South Africa
facility: Snake Park, Soweto
state: Gauteng
Study officials:
affiliation: University of Johannesburg
name: Makhutsisa C Mokoatle, Masters
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical Research Council, South Africa
name: Vusumuzi Nkosi, PhD
role: STUDY_DIRECTOR
References:
citation: Mokoatle C, Mathee A, Street R, Nkosi V. A study protocol to evaluate the impact of a personal and domestic hygiene intervention on lead exposure in a community next to a mine dump. BMC Public Health. 2022 Jun 4;22(1):1123. doi: 10.1186/s12889-022-13439-8.
Clinical trial NCT01353872: Nutrition Effects on Fatigue During Tennis Playing
Official title: Effects of Ingestion of Different Sports Drinks on Fatigue During Playing Tennis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Keywords: Fatigue
Tennis
Nutrition
Tournament simulation
Delivery of Health Care
Lead sponsor: Lescuyer Laboratory
Sponsor class: INDUSTRY
Collaborators: name: Service de Médecine du Sport et des Explorations Fonctionnelles - CHU G Montpied - Clermont-Ferrand
name: Université Blaise Pascal, Clermont-Ferrand
First posted: 2011-05-16
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The main objective of this study is to investigate the effects of ingestion of different sports drinks (Nutrattente / Nutraperf / Nutrarecup) on fatigue induced by a tennis tournament simulation.


Eligibility criteria: Inclusion Criteria:

* About 18 to 35 years (inclusive) Subject has a stable weight for at least three months before the start of the study
* Subject able and willing to comply with the protocol and agreeing to give their consent in writing
* Subject affiliated with a social security scheme
* Subject willing to be included in the national register of volunteers who lend themselves to biomedical research

Primary outcomes:
measure: peripheral fatigue measured by surface electromyographic (EMG) signal from the right triceps muscle
timeFrame: 3 matches (1.5 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Aubiere
country: France
facility: Sirvent
Study officials:
affiliation: Lescuyer Laboratory
name: Sebastien Peltier, PhD
role: STUDY_DIRECTOR
References:
citation: Brink-Elfegoun T, Ratel S, Lepretre PM, Metz L, Ennequin G, Dore E, Martin V, Bishop D, Aubineau N, Lescuyer JF, Duclos M, Sirvent P, Peltier SL. Effects of sports drinks on the maintenance of physical performance during 3 tennis matches: a randomized controlled study. J Int Soc Sports Nutr. 2014 Sep 2;11:46. doi: 10.1186/s12970-014-0046-7. eCollection 2014.
Clinical trial NCT05743972: Contrast-Enhanced Ultrasound vs Conventional US-guided Percutaneous Needle Biopsy for Pancreatic Diseases: Prospective Multicenter Randomized Controlled Trial
Official title: Contrast-Enhanced Ultrasound vs Conventional US-guided Percutaneous Needle Biopsy for Pancreatic Diseases: Prospective Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pancreatic Disease
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-02-24
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: According to previous studies, contrast-enhanced ultrasound (CEUS) -guided Core Biopsy(GB) could improve the diagnosis of biopsy in liver and other superficial mass compared to conventional US-GB. The purpose of this randomized trial is to estimate whether CEUS-GB achieve excellent diagnostic value to conventional US-GB in percutaneous biopsy for pancreatic diseases.

Detailed description: The patients with pancreatic diseases who need receive percutaneous biopsy were randomized with 1:1 ratio into undergo CEUS-GB group and conventional US-GB group.The aims include:

Comparison the diagnostic accuracy rate between CEUS and US group. Comparison the diagnostic specificity, sensitivity and complication rate between CEUS and US group.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years, WHO/ECOG scores \<2;
* Radiographic examination reveal focal pancreatic lesions;
* No history of local treatment for pancreatic lesions, systemic chemotherapy, targeting, immunotherapy, etc;
* Normal organ function, including the following criteria:

  1. Routine blood test: Hb≥80 g/L; PLT≥50×109/L;
  2. Coagulation function test: PT\<20s.

Exclusion Criteria:

* The lesions could not be shown by ultrasound and contrast-enhanced ultrasound;
* Allergic to ultrasound contrast agent;
* Cardiovascular and cerebrovascular diseases, liver, kidney and lung failure with significant clinical symptoms;
* History of unexplained bleeding, severe anemia, bleeding tendency or uncorrected coagulopathy;
* Combined with active infection;
* Massive ascites;
* Patients or family members do not agree to enter the study;
* Pregnant or lactating women;
* The investigator considers that there are any other factors that may be inappropriate for inclusion or affect the subject's participation in the study.

Primary outcomes:
measure: Diagnostic accuracy rate
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
state: Fujian
Study officials:
References:
Clinical trial NCT00892372: Relationship Between Body Weight and Glycohemoglobin
Official title: Relationship Between Changes in Body Weight and Glycohemoglobin Levels in Patients With Type 2 Diabetes Treated With Diet or Pioglitazone.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Keywords: body weight
glycohemoglobin
Lead sponsor: Saitama Medical University
Sponsor class: OTHER
First posted: 2009-05-04
Enrollment: 100
Sex: ALL
Minimum age (years): 32
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: Control of body weight (BW) is important to prevent and manage type 2 diabetes. Regardless of the close association, little is understood about the precise relationship between BW and glycemic control, which might be of benefit for patients with type 2 diabetes. The researchers investigated the correlation between changes in BW and glycemic control in patients with type 2 diabetes treated with a diet therapy or pioglitazone.


Eligibility criteria: Inclusion Criteria:

* type 2 diabetes under reasonable glycemic control (HbA1c; less than around 7%)
* type 2 diabetic patients treated with the diet therapy

Exclusion Criteria:

* type 2 diabetic patients with edema, severe liver dysfunction, renal dysfunction, moderate to severe anemia or congestive heart failure
* type 2 diabetic patients treated with insulin therapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kawagoe
country: Japan
facility: Department of Diabetes and Endocrinology, Saitama Medical Center, Saitama Medical University
state: Saitama
Study officials:
affiliation: Department of Diabetes and Endocrinology, Saitama Medical Center, Saitama Medical University
name: Eiji Ohmura, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03784872: Laparoscopic Ventrosuspension for Women With Retroverted Uterus and Pelvic Pain Syndromes: A New Approach
Official title: Laparoscopic Ventrosuspension for Women With Retroverted Uterus and Pelvic Pain Syndromes: A New Approach
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pelvic Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-12-24
Enrollment: 50
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In women with retroverted retroverted uterus complaining of pelvic pain, Laparoscopy was done. Under vision the skin overlying the attachment of the round ligament to the anterior abdominal wall was incised followed by introduction of 30 curved needle attached to absorpable Vicryl 2/0 suture through the incision and withdrawn through grasper under laparoscopi vision. The needle was turned around the round ligament all through its length to plicate it then the needle was pushed again beside its entry side to appear at the skin incision. The same was repeated on the other side and both sutures were tied at the subcutaneous tissue simultaneously. then the laparoscopy was withdrawn followed by closure of the skin incision.

Detailed description: In women with retroverted retroverted uterus complaining of pelvic pain, Laparoscopy was done. Under vision the skin overlying the attachment of the round ligament to the anterior abdominal wall was incised followed by introduction of 30 curved needle attached to absorpable Vicryl 2/0 suture through the incision and withdrawn through grasper under laparoscopi vision. The needle was turned around the round ligament all through its length to plicate it then the needle was pushed again beside its entry side to appear at the skin incision. The same was repeated on the other side and both sutures were tied at the subcutaneous tissue simultaneously. then the laparoscopy was withdrawn followed by closure of the skin incision using Vicryl 2/0 suture.

Eligibility criteria: Inclusion Criteria:

* women with chronic pelvic pain for more than 6 months duration
* women with retroverted retroflexed uterus
* no response to analgesics
* fit for laparoscopic surgery

Exclusion Criteria:

* Women with other causes of pelvic pain as ovarian cysts
* women with neurological disorders
* psychologically disturbed,
* Women with systemic or pelvic infections,

Primary outcomes:
measure: Postoperative pain: VAS
timeFrame: 6 months after the operation
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy medical school
Study officials:
affiliation: Professor
name: Ahmed Maged, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01459172: Human Breast Tissue Bioavailability of Topically Applied Limonene
Official title: Human Breast Tissue Bioavailability of Topically Applied Limonene
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Keywords: breast cancer prevention
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2011-10-25
Enrollment: 103
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The overall objective of this project is to determine the safety and breast tissue bioavailability of limonene following massage application of limonene containing massage oil to the breast.


Eligibility criteria: Inclusion Criteria:

* Women who are 18-65 years of age
* ECOG performance status 0-1
* Normal organ and marrow function
* Women of child-bearing potential must agree to use adequate contraception
* Willing to avoid consumption and use of citrus or citrus containing products throughout the study
* Have both breasts intact

Exclusion Criteria:

* Have had cancer(s) within the past 5 years
* Participated in another clinical interventional trial within the past 3 months
* Uncontrolled intercurrent illness
* Pregnant or breast feeding
* Unable to produce nipple aspirate fluid
* Have known allergic or sensitive reactions to skin care products, citrus or coconut oil
* Have ongoing skin disorders such as eczema and psoriasis

Primary outcomes:
measure: breast tissue bioavailability
timeFrame: 4 weeks
Secondary outcomes:
measure: safety
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Tucson
country: United States
facility: The University of Arizona Cancer Center
state: Arizona
Study officials:
affiliation: The University of Arizona
name: Sherry Chow, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02439372: Assessment of CMV-specific ELISPOT Assay for Predicting CMV Colitis in Patient With Ulcerative Colitis
Official title: Assessment of CMV-specific ELISPOT Assay for Predicting CMV Colitis in Patient With Ulcerative Colitis (ACE-UC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis
Cytomegalovirus Infections
Disease Exacerbation
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2015-05-08
Enrollment: 80
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Moderate to severe ulcerative colitis (Eligible patients had active UC with a Mayo score of 6-12 points)

Brief summary: Consequences of latent cytomegalovirus (CMV) infection reactivation on ulcerative colitis flare, as a flare-worsening factor or simple bystander, are debated. Theoretically, CMV-specific cell-mediate immune response will further categorize the patients into high or low risk of CMV colitis. The investigators thus evaluate the usefulness of CMV-specific ELISPOT assay in patient with ulcerative colitis flare to assess the the impact of CMV colitis on ulcerative colitis flare.

Detailed description: Moderate to severe ulcerative colitis patients admitted in Inflammatory Bowel Disease (IBD) center will be enrolled in this study. Eligible patients had active UC with a Mayo score of 6-12 points (moderate or severe disease activity). The investigators will evaluate whether CMV-specific cell-mediated immune response at admission will predict the risk of active cytomegalovirus infection (true pathogen versus bystander).

Eligibility criteria: Inclusion Criteria:

* moderate to severe UC require hospitalization
* age 16 or more
* agree with written informed consent

Exclusion Criteria:

* pregnancy
* foreign
* immunosuppressed patients

Primary outcomes:
measure: CMV infection
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary outcomes:
measure: Viral clearance from colonic mucosa
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: Breakthrough CMV infection
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Sung-Han Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jung KH, Kim J, Lee HS, Choi J, Jang SJ, Jung J, Kim MJ, Chong YP, Lee SO, Choi SH, Kim YS, Woo JH, Park SH, Yang DH, Ye BD, Yang SK, Kim SH. Clinical Implications of the CMV-Specific T-Cell Response and Local or Systemic CMV Viral Replication in Patients With Moderate to Severe Ulcerative Colitis. Open Forum Infect Dis. 2019 Dec 18;6(12):ofz526. doi: 10.1093/ofid/ofz526. eCollection 2019 Dec.
Clinical trial NCT06130072: Hysteroscopic Tubal Occlusion Using Amacrylate With or Without Lipidol in Patients With Hydrosalpinx Prior to IVF
Official title: Hysteroscopic Tubal Occlusion Using Iso-amyl- 2-cyanoacrylate With or Without Ethiodized Oil (Lipidol) in Patients With Hydrosalpinx Prior to IVF
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Effectiveness of Isoamyl-2-cyanoacrylate With and Without Ethiodized Oil in Occluding Hydrosalpinx Prior to IVF
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 45
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Hysteroscopic tubal occlusion using iso-amyl- 2-cyanoacrylate with or without Ethiodized oil (Lipidol) in patients with hydrosalpinx prior to IVF
Primary purpose: BASIC_SCIENCE

Brief summary: Hysteroscopic tubal occlusion using iso-amyl- 2-cyanoacrylate with or without Ethiodized oil (Lipidol) in patients with hydrosalpinx prior to IVF

Detailed description: hysteroscopic injection of iso-amyl- 2-cyanoacrylate with or without Ethiodized oil (Lipidol) in patients with hydrosalpinx requiring IVF. after one months and two months of the primary injection hysterosalpingography will be done to test for tubal occlusion.

Eligibility criteria: Inclusion Criteria: • Infertile women due to tubal factor with hydrosalpinx (unilateral or bilateral) prepared for IVF

Exclusion Criteria:

* • Any patient with acute pelvic inflammatory disease, endometritis, lower genital tract infection.

  * The presence of intrauterine synechiae that might hinder the proper hysteroscopic examination and tubal cannulation diagnosed by diagnostic hysteroscopy.
  * The presence of uterine anomalies that might hinder the proper hysteroscopic examination and tubal cannulation diagnosed by diagnostic hysteroscopy.
  * Undiagnosed genital bleeding.

Primary outcomes:
measure: Fallopian tube occlusion
timeFrame: one to three months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04053972: The Impact on Recurrence Risk of Adjuvant Lenvatinib for Patients With Hepatocellular Carcinoma And Microvascular Invasion (MVI) After Hepatectomy : A Random, Controlled, Stage III Clinical Trial.
Official title: The Impact on Recurrence Risk of Adjuvant Lenvatinib for Patients With Hepatocellular Carcinoma And Microvascular Invasion (MVI) After Hepatectomy : A Random, Controlled, Stage III Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hepatocellular Carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-08-13
Enrollment: 377
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: To compare The Impact on Recurrence Risk of Adjuvant Lenvatinib for Patients With Hepatocellular Carcinoma And Microvascular Invasion (MVI) After Hepatectomy.


Eligibility criteria: No

Criteria:

Inclusion Criteria:

older than 18 years old and younger than 75 years; ECOG PS\<3; proven hepatocellular carcinoma with MVI according pathological examination; not previous treated for tumor; tumor was removed in operation; no recurrence occurence at 4 to 7 weeks after surgery; the lab test could meet: neutrophil count≥1.5×109/L; hemoglobin≥80g/L; platelet count≥60×109/L; serum albumin≥28g/L; total bilirubin\<3-times upper limit of normal; ALT\<5-times upper limit of normal; AST\<5-times upper limit of normal; serum creatine\<1.5-times upper limit of normal; PT≤upper limit of normal plus 6 seconds; INR≤2.3; sign up consent; unrolled by other clinical trials about hepatocellular carcinoma.

Exclusion Criteria:

cannot tolerate lenvatinib; CNS or bone metastasis exits; known history of other malignancy; be allergic to related drugs; underwent organ transplantation before; be treated before (interferon included); known history of HIV infection; known history of drug or alcohol abuse; have GI hemorreage or cardiac/brain vascular events within 30 days; pregnancy;

Primary outcomes:
measure: RFS
timeFrame: From date of randomization until the date of recurrence, assessed up to 60 months
Secondary outcomes:
measure: OS
timeFrame: From date of randomization until the date of death from any cause, assessed up to 60 months
measure: recurrence rate
timeFrame: 1 year, 2 year, 3 year, 5 year after surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: SUN YAT-SEN University Cancer Center
state: Guangdong
Study officials:
References: