louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01024465: ReShape Intragastric Balloon for the Treatment of Obesity
Official title: ReShape Intragastric Balloon for the Treatment of Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity
intragastric balloon
Lead sponsor: ReShape Lifesciences
Sponsor class: INDUSTRY
Collaborators: name: Regional Hospital. Viale Rodolfi 37. 36100 Vicenza. ITALY
name: Casa di Cura Solatrix. Via Bellini 11. 38068 Rovereto. ITALY
First posted: 2009-12-02
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A prospective, non-randomized, open-label, multi-center study designed to implant up to twenty-six (26) CE-marked ReShape™ Balloons in twenty-six (26) patients with body mass index (BMI) 30-40 to assess the effectiveness of the device. The RIB devices will be used within their labeled indications and as per their instructions for use. Enrolled patients will be followed for seven months. The patient will be prescribed a controlled diet, exercise and counseling. One group of 26 patients will receive treatment as follows: Placement, inflate to 900 cc, remove at 180 days, follow-up 30 days post removal (endoscopic video capture of placement and removal required).


Eligibility criteria: Inclusion Criteria:

* The patient is male or female between the ages of 20 and 60 years of age.
* The patient presents with a Body Mass Index (BMI) 30-40 kg/m2.
* The patient is geographically stable and willing to return to the implant center for follow-up visits.
* The patient has been adequately informed of risks and requirements and consents to his/her participation in the post market clinical study.

Exclusion Criteria:

* The patient presents with 20 years \> Age \> 60 years.
* The patient has a progressive disease, which in the Investigator's experience produces an unacceptable increased risk to the patient, or results in a life expectancy of less than 12 months.
* The patient is a pregnant or lactating female.
* The patient presents with a 30 kg/m2 \> BMI \> 40 kg/m2.
* The patient has had previous abdominal surgery.
* The patient has digestive tract disorders such as active peptic ulcers, bleeding disorders, esophageal varices, Crohn's disease.
* The patient presents with psychiatric disorders.
* The patient is participating in concomitant research studies of investigational products that would interfere with this study.
* The patient has inability to return for follow-up assessments.
* The patient is an alcohol or drug abuser.

Primary outcomes:
measure: Total Weight Loss
timeFrame: baseline to 180 days
Secondary outcomes:
Other outcomes:
Locations:
city: Rovereto
country: Italy
facility: Casa di Cura Solatrix
city: Vicenza
country: Italy
facility: Regional Hospital
Study officials:
affiliation: ReShape Medical
name: Mary Lou Mooney
role: STUDY_DIRECTOR
References:
Clinical trial NCT03147365: Effect of Different Exercises on Quality of Life of Leukemia Patients.
Official title: Aerobic Training Versus Strength Exercises on Quality of Life and Functional Capacity on Children With Leukemia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Acute Lymphoblastic Leukemia
Exercise
Lead sponsor: Children's Cancer Hospital Egypt 57357
Sponsor class: OTHER
First posted: 2017-05-10
Enrollment: 75
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental controlled randomization using Block Stratified Randomized Software program, after obtaining informed consent from illegible patient or his caregiver.
Primary purpose: OTHER

Brief summary: * To compare between modified strength training program and aerobic exercises on quality of life on children with Acute Lymphoblastic Leukemia.
* To compare between modified strength training program and aerobic exercises on functional capacity on children with Acute Lymphoblastic Leukemia.

Detailed description: This study will be done to determine any exercise from aerobic exercises or modified strength training program will be more effective on quality of life and functional capacity on children with Acute Lymphoblastic Leukemia .Acute Lymphoblastic Leukemia is wide spread in the world and the children with this disease are fragile so must know the most program effect.

Eligibility criteria: Inclusion Criteria:

* Age range from8-12years.
* Children during 3rd phase( maintenance phase of the treatment). According San et al(2007) who found children with Acute Lymphoblastic Leukemia in maintenance phase of treatment can safely perform both aerobic and resistance training .
* Time elapsed since the start of the maintenance phase \>20weeks.
* Children with muscle weakness due to chemotherapy.
* The height , weight and body mass index of the child will take on standard scale.
* preserved cardiac structure and function as assisted by echo-cardiogram.
* The children have ability to walk.

Exclusion Criteria:

Children who have one or more of the following criteria will be excluded from the study:

* Receiving more intensive chemotherapy.
* Mental disabled.
* Sever cardiomyopathy (ejection fraction \<40%, ECG will be used as a pretest as it might be a more sensitive tool to exclude angina pectoris).
* Low blood platelet levels (\< 50.000 per µl).
* Marked anemia (hemoglobin \< 8 g/dl).
* Severe cachexia (i.e., weight mass loss \> 35%).
* Pain in bone.
* Inability to walk.
* Sensory disturbance.
* Peripheral neuropathy.

Primary outcomes:
measure: Improvement of quality of life
timeFrame: at week 20
Secondary outcomes:
measure: Improvement of functional capacity
timeFrame: at week 20
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Children's Cancer Hospital Egypt 57357
Study officials:
affiliation: Children's Cancer Hospital Egypt CCHE 57357
name: Doaa M Khalifa, BSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04152265: Mycotoxin Exposure and Dietary Habits in Colorectal Cancer Prevention and Development Among Polish Population
Official title: Mycotoxin Exposure and Dietary Habits in Colorectal Cancer Prevention and Development Among Polish Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer, Somatic (Diagnosis)
Keywords: colorectal cancer
zearalenone
mycotoxin
gastrointestinal bacterial
Lead sponsor: University of Warmia and Mazury in Olsztyn
Sponsor class: OTHER
Collaborators: name: Provincial Specialist Hospital in Olsztyn
name: Ministry of Health Republic of Poland
First posted: 2019-11-05
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the study is the determination of the zearalenone and its metabolites (α and β) level in the blood plasma and faeces of patients at increased risk of cancer, in relation to the nutrition data (FFQ) and information on the quality of life dependent on health (WHOQOL-BREF).

The study is performer within the framework of the Polish Colonoscopy Screening Program. Within the study 100 volunteers between 50 and 65 years of age. while, the colonoscopies will be performed in Provincial Specialist Hospital in Olsztyn. Patients with positive test result, who have been diagnosed with polyps or cancer, will be assigned to risk group. The study has been approved by a local bioethics committee.


Eligibility criteria: Inclusion Criteria:

* Men and women aged from 50 to 65 years residing in Poland.

Exclusion Criteria:

* subjects requiring long-term care due to somatic, mental retardation or other mental illness.
* history of colorectal resection.

Primary outcomes:
measure: Completion of the assigned screening strategy
timeFrame: Within 8 weeks of enrollment
Secondary outcomes:
measure: Analysis of the concentration of the mycotoxin
timeFrame: 5 month
measure: Characteristics of gut bacterial
timeFrame: 6 month
measure: Determination of anthropometric data
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Olsztyn
country: Poland
facility: Provincial Specialist Hospital in Olsztyn
Study officials:
affiliation: Department of Human Nutrition, Faculty of Food Science, University of Warmia and Mazury
name: Tomasz Sawicki, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05201365: A Prospective Cohort Study of Compound Nanxing Zhitong Ointment
Official title: A Prospective Cohort Study of Compound Nanxing Zhitong Ointment in the Treatment of Chronic Musculoskeletal Pain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Musculoskeletal Pain
Lead sponsor: Jiangsu Kanion Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2022-01-21
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1. pain that meets the ICD-11 classification of chronic pain that is localized to the musculoskeletal system and occurs in the neck, shoulder, low back and extremities.
2. Those who meet the criteria of "cold" in Chinese medicine and whose chronic pain is exacerbated by cold.
3. Persistent/intermittent pain for more than 3 months and no indication for surgery.

Brief summary: The purpose of this study is to evaluate the safety and the efficacy of compound Nanxing pain relief cream in the treatment of chronic pain in the musculoskeletal system

Detailed description: Chronic pain, especially in the musculoskeletal system, is prevalent worldwide. Many studies show the burdens they impose: pain, disability, reduced quality of life (QoL), marked impairment of participation in work and social activities, and heavy financial costs.The purpose of this study is to evaluate the safety and the efficacy of compound Nanxing pain relief cream in the treatment of chronic pain in the musculoskeletal system. To provide a safe and effective treatment of Chronic Musculoskeletal Pain.

Eligibility criteria: Inclusion Criteria:

* Attendance at orthopedic, rheumatology and pain clinics for.

Exclusion Criteria:

* Indication for surgery.

Primary outcomes:
measure: Change in Overall Pain Assessment Scale score at week 12 overall Pain Assessment Scale score at week 12.
timeFrame: Change from Baseline GPS at week 12.
Secondary outcomes:
measure: Quality of Life Short Form12,SF-12
timeFrame: Total scores at baseline, week 2, week 4, week 8, and week 12 were evaluated in both groups.
measure: Pain resolution time
timeFrame: VAS is assessed within 1 hour ahead of the treatment and within 1 hour after the treatment. The change of the score indicate the treatment efficacy.
measure: Number of pain-free days per month
timeFrame: Records are taken every day by the end of the day. Records are assessed at the end of 12 weeks of treatment.
measure: Chinese medicine evidence score
timeFrame: The TCM evidence score was assessed within 1 hour after treatment. Changes in TCM evidence scores compared to baseline at week 12.
measure: Safety evaluation
timeFrame: After 12 weeks of treatment, evaluate adverse reactions and make a record.
Other outcomes:
Locations:
Study officials:
affiliation: Vice President of the Third Affiliated Hospital of Beijing University of Chinese Medicine
name: chen weiheng, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT04323865: Fetal Heart Rate Variability
Official title: Non-invasive Fetal Electrocardiography (NI-FECG); Repeatability of Time-domain and Spectral Analyses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fetal Growth Retardation
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation
name: Hartmann Fonden
name: Augustinus Fonden
name: The Dagmar Marshall Foundation
name: AP Moeller Foundation
name: Aalborg University
First posted: 2020-03-27
Enrollment: 75
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Danish. Healthy. Pregnant women. Expecting a healthy fetus.

Brief summary: Need statement

- a new way to distinguish between a healthy small fetus and a small fetus suffering from deprivation of nutrition and oxygen to prevent unnecessary induction of preterm birth and improve neonatal outcome.

Aim - to characterize fetal heart rate variability (fHRV) based on fetal ECG in the normal fetus and in the fetus suffering from growth retardation to evaluate its value and applicability as a supplementary tool in fetal surveillance.

Aim of current study

- To evaluate the feasibility of NI-FECG from gestational week 20 and onwards and investigate if important factors as length and heart rate pattern affects repeatability of time domain and spectral analyses in fetuses.


Eligibility criteria: Inclusion Criteria:

• Healthy singleton pregnancies

Exclusion Criteria:

• Fetal malformations, multiple pregnancy, obstetric complications, maternal chronic disease and labor.

Primary outcomes:
measure: Standard deviation of normal to normal RR-interval (SDNN)
timeFrame: 01.04.2020
measure: Root mean square of successive RR-interval differences (RMSSD)
timeFrame: 01.04.2020
measure: Low frequency power (LF-power)
timeFrame: 01.04.2020
measure: High frequency power (HF-power)
timeFrame: 01.04.2020
measure: LF-power/HF-power
timeFrame: 01.04.2020
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Arhus Universityhospital
state: Aarhus N
Study officials:
References:
Clinical trial NCT05976165: A Study of Breath Testing for Small Intestinal Bacterial Overgrowth
Official title: Breath Testing for Small Intestinal Bacterial Overgrowth in Patients Treated With Proton Pump Inhibitors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastroesophageal Reflux
Regurgitation
Heartburn
Keywords: Proton pump inhibitor
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-08-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Researchers hope to determine how often small intestinal bacterial overgrowth occurs after taking proton pump inhibitors.


Eligibility criteria: Inclusion criteria:

* Predominant symptoms of gastroesophageal reflux disease including heartburn, regurgitation
* Subjects must be able to give appropriate informed consent

Exclusion criteria:

* Prior diagnosis of SIBO
* Use of PPIs or H2R-anatagonstists in the prior 3 months
* Major concomitant illness (renal, hepatic, rheumatologic or cardiovascular disease, or malignancy)
* Antibiotic therapy within one month
* Prior gastrointestinal surgery including esophageal, gastric, and small or large bowel surgery
* Previously diagnosed irritable bowel syndrome or inflammatory bowel disease
* Individuals who are pregnant or breast feeding
* Patients with plans to become pregnant
* Inability to take PPIs, including allergy/sensitivity

Primary outcomes:
measure: Incidence of SIBO after treatment with PPI
timeFrame: After PPI therapy, approximately 8 weeks
Secondary outcomes:
measure: Symptoms of SIBO after treatment with PPI
timeFrame: After PPI therapy, approximately 8 weeks
measure: Incidence of SIBO before treatment with a PPI
timeFrame: Baseline
measure: Symptoms of SIBO before treatment with a PPI
timeFrame: Baseline
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Andree Koop, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03510065: Prevision® PMCF Study
Official title: Post Market Clinical Follow-Up Study Prevision®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Survival, Prosthesis
Keywords: hip arthroplasty
revision arthroplasty
survival
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2018-04-27
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving a Prevision® stem between 2002 and 2012

Brief summary: Monocentric, non-interventional Post-Market Clinical Follow-Up (PMCF) Study on past implantations of the Prevision® prosthesis; the survival rate of the Prevision® prosthesis shall be evaluated and compared to literature results on comparable Revision stems.


Eligibility criteria: Inclusion:

* Patient received a Prevision® Hip Stem (curved or straight) between 2002 an 2012
* Patient gave his written consent for study participation

Exclusion:

- none

Primary outcomes:
measure: Prevision® survival
timeFrame: 4-14 years after implantation
Secondary outcomes:
measure: Clinical Results
timeFrame: 4-14 years after implantation
measure: Ectopic Ossification
timeFrame: 4-14 years after implantation
measure: Sinking / Migration of the Stem
timeFrame: 4-14 years after implantation
measure: Radiological Evaluation of the Stem
timeFrame: 4-14 years after implantation
measure: Quality of Life
timeFrame: 4-14 years after implantation
measure: Pain
timeFrame: 4-14 years after implantation
measure: Adverse Events
timeFrame: 4-14 years after implantation
measure: Serious Adverse Events
timeFrame: 4-14 years after implantation
Other outcomes:
Locations:
city: Bad Hersfeld
country: Germany
facility: Klinikum Bad Hersfeld
Study officials:
References:
Clinical trial NCT02537665: Heating Precondition of Epidural Catheter Decrease the Incidence of Injury to Blood Vessel During Epidural Catheter Placement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Epidural Anesthesia
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2015-09-01
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To explore the effect of heating precondition of epidural catheter on the incidence of injury to blood vessel during epidural catheter placement.


Eligibility criteria: Inclusion Criteria:

* Elective cesarean delivery
* Epidural anesthesia.

Exclusion Criteria:

* blood coagulation disorders

Primary outcomes:
measure: the incidence of injury to blood vessel during epidural catheter placement
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT03298165: The Microbiological Assessment of Deep Carious Lesions After Step-wise Excavation and Diode Laser Cavity Disinfection .
Official title: Diode Laser Cavity Disinfection (A Six Month Randomized Clinical Trial).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Antibacterial Effect of Diode Laser
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-10-02
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will be conducted to assess antibacterial effect of the diode laser in deep carious cavity after step wise excavation using the bacteriological assessment method.

Detailed description: each patient should have at least two deep carious lesions The first clinical step in all teeth will be the opening of the cavity and the removal of undermined enamel . Caries at the lateral walls of the cavity and at the enamel-dentin junction was completely removed with excavators and/or round carbide burs at low speed. Subsequently, the central cariogenic biomasses and superficial part of the necrotic and demineralized dentin were removed. then excavation continued until the pulp exposure would occur with further excavation; thus, a layer of soft carious dentin was left on the cavity floor adjacent to the pulp wall.

A dentine samples will be then collected from the base of the cavity using sterile spoon excavator from the both groups for baseline bacteriological assessment and another sample will be taken after disinfection with diode laser in the intervention group .

In the two groups The remaining innermost layer of carious dentin are covered with calcium hydroxide The cavity was then sealed with restorative material (resin modified glass ionomer) after a 6 month period. This time was considered adequate for calcium hydroxide to exert its effect and for the pulp to respond with possible formation of tertiary dentin. The teeth were followed up every month and the integrity of the temporary restoration checked. After this interval of 6 months. After the rubber dam application, the temporary filling is removed samples are collected and the teeth are finally restored

Eligibility criteria: Inclusion Criteria:

1. Patients with at least two deep occlusal carious lesion .
2. 18 - 25years.
3. Males or Females.
4. Good oral hygiene.
5. Co-operative patients approving the trial and willing to sign a written consent.

Exclusion Criteria:

1. Pregnancy.
2. Systemic disease or severe medical complications.
3. Heavy smoking.
4. Xerostomia.
5. Lack of compliance.
6. Evidence of temporomandibular joint disorders.

Primary outcomes:
measure: bacteriological count
timeFrame: 30 minute
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00826865: Bioequivalency Study of Levetiracetam 750 mg Tablets Under Fasting Conditions
Official title: A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Levetiracetam 750 mg Tablets Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Seizures
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2009-01-22
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to prove the bioequivalence of Levetiracetam 750 mg Tablets under fasted conditions


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to Levetiracetam or any comparable or similar product.

Primary outcomes:
measure: bioequivalance based on Cmax
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: MDS Pharma Services
state: Arizona
Study officials:
affiliation: MDS Pharma Services
name: Mark Allison, MD
role: PRINCIPAL_INVESTIGATOR
References: