louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02492451: Endometrial Injury Versus Luteal Phase Support in Intrauterine Insemination Cycles
Official title: Endometrial Injury Versus Luteal Phase Support in Intrauterine Insemination Cycles
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pregnancy
Keywords: intrauterine insemination
pregnancy rate
endometrial injury
Lead sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Sponsor class: OTHER
First posted: 2015-07-08
Enrollment: 118
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators will try to assess the effect of endometrial injury preceding the intrauterine insemination cycle on the pregnancy rates compared to cycles with luteal phase support and the control group.

Detailed description: Group 1: Endometrial biopsy is performed on days 21-24 of the spontaneous menstrual cycle proceeding the intrauterine insemination (IUI) treatment cycle. Two small biopsies are obtained from anterior and posterior walls of the uterus.

Group 2: Vaginal progesterone gel is administered for luteal phase support from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.

Goup 3: Patients are undergone intrauterine insemination (IUI) cycles stimulated with gonadotropin without any intervention.

The effect of endometrial injury and luteal phase progesterone support on the pregnancy rate in patients intrauterine insemination (IUI) cycles stimulated with gonadotropin will be compared in terms of biochemical pregnancy rate, clinical pregnancy rate and ongoing pregnancy rate.

Eligibility criteria: Inclusion Criteria:

* Patients are undergone intrauterine insemination with gonadotropin stimulation
* Bilateral patent fallopian tubes revealed by hysterosalpingography or laparoscopy
* After semen preparation for intrauterine insemination, total progressive sperm count \> 5 million

Exclusion Criteria:

* endocrin or metabolic disorders,
* uterine factor,
* pelvic inflammatory disease,
* women with basal follicle-stimulating hormone (FSH) level \>15 IU/mL,
* body mass index (BMI) ≥ 35 kg/m2,
* age ≥ 40 and \< 18 years,

Primary outcomes:
measure: Pregnancy Rate
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Selcuk Selcuk
Study officials:
References:
citation: Bui BN, Lensen SF, Gibreel A, Martins WP, Torrance H, Broekmans FJ. Endometrial injury for pregnancy following sexual intercourse or intrauterine insemination. Cochrane Database Syst Rev. 2022 Oct 24;10(10):CD011424. doi: 10.1002/14651858.CD011424.pub4.
citation: Bui BN, Lensen SF, Gibreel A, Martins WP, Torrance H, Broekmans FJ. Endometrial injury for pregnancy following sexual intercourse or intrauterine insemination. Cochrane Database Syst Rev. 2021 Mar 18;3(3):CD011424. doi: 10.1002/14651858.CD011424.pub3.
Clinical trial NCT00181051: Clinical Utility of the Alaris MidLatencyAuditoryEvoked Potentials Monitor to Titrate the Anesthetic-Hypnotic Component of Anesthesia
Official title: Clinical Utility of the Alaris MidLatencyAuditoryEvoked Potentials Monitor to Titrate the Anesthetic-Hypnotic Component of Anesthesia
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE3
Conditions: Scheduled General Anesthesia
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Index computed in real time from Auditory Evoked Potentials have been described parallel to depth of anesthesia. The goal of the study was to compare general anesthesia guided on Auditory Evoked Potentials monitoring to standrad practice in order to assess if AEP monitoring can improve recovery delay (main criteria) or intraoperative hemodynamic stability (secondary criteria). Patients were randomized in 2 groups, stratified by center. Group I : AEP guided anesthesia, Group II: Blind AEP record, standard practice.


Eligibility criteria: Inclusion Criteria:

* ASA status I-II patients
* aged 18 - 65 years
* scheduled for general surgery (except laparoscopic interventions) lasting longer than 1 hour.

Exclusion Criteria:

* Body weight \< 70% or \> 150% ideal body weight
* neurological disorder and hearing disorders (being not able to communicate with the patient in a normal tone)
* use of any medication interfering with pharmacological effect of the study including alcohol misuse or drugs.

Primary outcomes:
measure: Influence of AEP guided anesthesia on recovery delay
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Institut Gustave-Roussy
Study officials:
affiliation: CHU de GENT - BELGIUM
name: Michel STRUYS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01755351: Comparative Study About the Influence of Diabetes Diatress and Depression on Treatment Adherence in Chinese Type 2 Diabetes Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Compare Diabetes Distress and Depression
Lead sponsor: Shandong Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2012-12-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with type 2 diabetes who visited the two local hospitals between December 2011 and April 2012, were invited to participate in this cross-sectional survey study.

Brief summary: An effective treatment adherence was a key to make the treatment success, some reports had shown that psychologicl factors impact patients adherence seriously,however, in China, the researches were only limited to depression and diabetes,diabetes distress was neglected. Some western studies had demonstrated the impact of diabetes distress on diabetes. Thus, we hypothesized that: 1.perhaps our present depression-oriented health education was inadequate to promote patients' adherence, diabetes distress might played a more important part than depression in patients' treatment adherence. 2. there might be a high prevalence of diabetes distress in Chinese type 2 diabetes; so, the comparative study between diabetes distress and depresion was conducted.

Objectives: to explore the relationship of diabetes-related distress and depression，and to compare the influence of diabetes distress and depression on treatment adherence in Chinese type 2 diabetes .

Research design and method:we surveyed 200 type 2 diabetic patients from 2 third-class hospitals using the Diabetes Distress Scale, Zung Self-rating Depression Scale, and Revised Treatment Adherence in Diabetes Questionnaire (RADQ)simultaneously.


Eligibility criteria: Inclusion Criteria:

* 1)aged between 18-80 years, 2)diagnosed with diabetes for at least 6 month, 3) having the ability to communicate fluently and clearly,

Exclusion Criteria:

* patients who had the diagnosis of dementia or psychosis and severe diabetes complications (e.g., on dialysis)

Primary outcomes:
measure: The influence of diabetes distress on treatment sdherence
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qianfoshan Hospital Shandong province
Study officials:
References:
Clinical trial NCT03111251: Multi-component Interventions to Increase HPV Vaccination in a Network of Pediatric Clinics
Official title: Multi-component Interventions for Patients and Providers to Increase HPV Vaccination in a Network of Pediatric Clinics in Houston, TX
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Papillomavirus (HPV)
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Cancer Prevention Research Institute of Texas
name: Baylor College of Medicine
First posted: 2017-04-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to determine the comparative effectiveness of a provider-only intervention and a parent plus provider intervention to increase initiation of HPV vaccination among male and female patients ages 11-17 in a large pediatric clinic network in the greater Houston area. The hypothesis is that HPV vaccine initiation will be higher in clinics randomized to the parent plus provider intervention compared with clinics randomized to the provider-only intervention.


Eligibility criteria: Inclusion Criteria:

* Patient at a Texas Children's Pediatrics clinic
* Patient had not initiated the HPV vaccination series at baseline

Exclusion Criteria:

- Patient had completed the HPV vaccination series at baseline

Primary outcomes:
measure: Change in percent of HPV vaccination initiation
timeFrame: baseline, 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Sally W Vernon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05722951: Metformin Efficacy and Safety in Epileptic Patients
Official title: Metformin Efficacy and Safety in Epileptic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-02-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to Evaluating Metformin Efficacy and Safety when Co-administered with Antiepileptic Drugs in Patients with Seizures. The main question it aims to answer is:

* Does metformin have beneficial effect on epileptic patients?
* How metformin can affect epileptic patient's health?

Participants will be divided into 2 groups (control group and treatment group)

* Control group will receive standard treatment (levetiracetam \&/or sodium valproate).
* Treatment group will receive standard treatment (levetiracetam \&/or sodium valproate) + metformin


Eligibility criteria: Inclusion Criteria:

* Age: 18 - 65 years old
* Obese and overweight patients with body mass index (BMI) ≥ 25.
* Diabetic \& non diabetic patients.

Exclusion Criteria:

* Patients with severe liver damage or kidney disease (eGFR below 45mL/min/1.73 m²).
* Patients having acute or chronic disease which may cause tissue hypoxia and increase the risk of lactic acidosis (e.g. cardiac/respiratory failure, recent myocardial infarction).
* Patients who are already taking metformin.
* Cancer patients.
* Pregnant or lactating women.
* Patients with known hypersensitivity to the drug.

Primary outcomes:
measure: Seizures Frequency
timeFrame: 6 months
measure: Seizures Severity
timeFrame: 6 months
measure: Quality of Life level
timeFrame: 6 months
Secondary outcomes:
measure: Change in BMI
timeFrame: 6 months
measure: Change in biological markers
timeFrame: 6 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Omnia Ashraf Abd El Aziz Ahmed Kotb
Study officials:
References:
Clinical trial NCT02288351: Intestinal Remodeling And Reprogramming of Glucose Metabolism Following Laparoscopic Roux-en-Y Gastric Bypass
Official title: Intestinal Remodeling And Reprogramming of Glucose Metabolism Following Laparoscopic Roux-en-Y Gastric Bypass
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Type 2 Diabetes
Obesity
Keywords: Roux-en-Y gastric bypass
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Society of American Gastrointestinal and Endoscopic Surgeons
First posted: 2014-11-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate small intestinal remodeling and reprogramming of glucose metabolism in patients with Type 2 Diabetes Mellitus (T2DM) who undergo laparoscopic Roux-en-Y Gastric Bypass (RYGB). Our specific goal is to determine if the gene and protein expression levels of GLUT-1 are up regulated in the Roux limb and whether this is a major mechanism for the remission of T2DM following RYGB.

The two aims of the study are: 1) to demonstrate that the basement membrane glucose transporter 1 (GLUT-1) is upregulated in the Roux limb following RYGB, and 2) to demonstrate that the upregulation of GLUT-1 is a major mechanism for the improvement in glycemic control observed in T2DM patients undergoing RYGB.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of Type 2 Diabetes Mellitus
2. Age between 18 and 65 years of age
3. BMI \> 35kg/m²
4. Diagnosis of gastritis, esophagitis, ulcer, or other mucosal abnormality discovered at routine preoperative upper endoscopy, requiring follow-up endoscopy in the post-operative period.

Exclusion Criteria:

1. Patients undergoing revision from another bariatric procedure to RYGB
2. Presence of a seizure disorder (GLUT-1 deficiency syndrome)
3. Use of Tricyclic antidepressants
4. Use of tobacco products

Primary outcomes:
measure: Elevated Glut-1 gene and protein expression levels
timeFrame: 2 months
Secondary outcomes:
measure: Glut-1 level change in fasting glucose
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
affiliation: Duke University
name: Philip Omotosho, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05219851: The Risk Factors for Acute Radiation Pneumonitis in Patients With Prior Receipt of Immune Checkpoint Inhibitors
Official title: The Risk Factors for Acute Radiation Pneumonitis in Patients With Prior Receipt of Immune Checkpoint Inhibitors.in Real-world Clinical Practice: a Multicenter, Prospective, Open, Non-interventional Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer Patients
Keywords: IMRT
Radiotherapy
Immune checkpoint inhibitor
Pneumonitis
Risk factors
Lead sponsor: Hubei Cancer Hospital
Sponsor class: OTHER
First posted: 2022-02-02
Enrollment: 250
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: All patients treated with the product will be enrolled in the investigation

Brief summary: The purpose of this non-interventional study is to collect data on the risk factors for acute radiation pneumonitis in patients with prior receipt of immune checkpoint inhibitors.

Detailed description: 1. Incidence of acute radiation pneumonitis (aRPs) in in patients with prior receipt of immune checkpoint inhibitors.
2. Risk factors (especially analysis of the dosimetric risk factor) which may affect the product of aRPs events.
3. Establish a model to predict aRPs and guide clinical treatment.

Eligibility criteria: Inclusion Criteria:

1. Pathologically or cytologically confirmed malignant tumor
2. Cancer patients with previously received ICIs underwent thoracic intensity-modulated radiotherapy

Exclusion Criteria:

1. Cancer patients did not receive immunotherapy before thoracic intensity-modulated radiotherapy
2. Non-thoracic radiotherapy patients

Primary outcomes:
measure: Incidence of acute radiation pneumonitis (aRPs) in patients with prior receipt of immune checkpoint inhibitors.
timeFrame: 6 months after last-patient- radiation
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
Study officials:
References:
Clinical trial NCT01377051: Effect of Indacaterol Maleate in Chronic Obstructive Pulmonary Disease (COPD) on Lung Volume and Related Dyspnea
Official title: Acute Effect of Indacaterol Maleate on Static and Dynamic Lung Volume in COPD Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: COPD
Lung Diseases
Dyspnea
Hypoxemia
Tachycardia
Keywords: COPD
Inspiratory capacity
Residual volume
Total lung resistance
Arterial Oxygen
Lead sponsor: University of Milan
Sponsor class: OTHER
Collaborators: name: Fondazione Salvatore Maugeri
First posted: 2011-06-20
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether indacaterol maleate 300 micrograms (mcg) is effective in the acute treatment of COPD and in particular on reducing lung hyperinflation and dynamic volumes.

Detailed description: Enrolled patients: COPD of any disease severity in stable conditions. 48 hours of inhalatory drugs wash out.

Evaluation: Plethysmographic test, blood gas analysis, blood pressure, cardiac frequency and Borg scale evaluation in basal condition and after 60 minutes of indacaterol maleate 300 mcg inhalation.

Eligibility criteria: Inclusion Criteria:

* Signature of consensus
* COPD diagnosis
* Age from 50 to 85 years old
* history of COPD at least of one year
* respiratory stable conditions at least of one month
* Any basal FEV1 expressed in % of predicted value
* FEV1/ Forced Vital Capacity (FVC) less than 70%
* Former or active smokers with at least a smoking history of 20 pack year

Exclusion Criteria:

* Pregnancy
* FEV1/FVC more than 70%
* Known deficit of alpha 1 antitrypsin
* Subjects submitted to a Lung Volume Reduction Surgery (LVRS)
* Subjects with known positivity to Human Immunodeficiency Virus (HIV)
* Misuse of alcool or drugs
* Absence of compliance in performing respiratory tests

Primary outcomes:
measure: Intra Thoracic Gas Volume (ITGV)
timeFrame: 60 minutes after drug inhalation
Secondary outcomes:
measure: Forced Expired Volume in the first second (FEV1)
timeFrame: 60 minutes after drug inhalation
measure: Partial pressure of arterial oxygen (PaO2)
timeFrame: 60 minutes after drug inhalation
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Pneumologia Riabilitativa - Fondazione Maugeri - Istituto Scientifico di Milano - IRCCS
Study officials:
affiliation: Università degli Studi di Milano-Pneumologia Riabilitativa- Fondazione Maugeri-Istituto Scientifico di Milano-IRCCS - pierachille.santus@unimi.it
name: Pierachille Santus, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01781351: Neuromuscular Control of the Ankle With External Support
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Ankle Instability
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2013-02-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Untreated ankle sprains often remain symptomatic and may end in chronic instability. The aim of our study is to quantify the stabilizing effect of different devices. Through the combined use of the 3D motion analysis and the surface electromyography, the influence of the devices with respect to a mechanical effect and to an influence on the neuromuscular control are examined. The tests will simulate situations with a higher risk of injury. In the experimental set-up, an element of surprise will be integrated in order to analyze any muscular compensation mechanisms.


Eligibility criteria: Inclusion Criteria:

* chronic ankle instability
* "giving way"
* repeated ankle sprains

Exclusion Criteria:

* other injuries of the lower extremities
* surgery on the lower extremities

Primary outcomes:
measure: Change in elektromyographic signal in peroneus longus muscle (surface EMG)
timeFrame: baseline (=before) and immediately after applying the device
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Department of Orthopedics, Trauma Surgery and Spinal Cord Injury, Heidelberg University Hospital
Study officials:
affiliation: Dep. of Orthopedics, Trauma Surgery and Spinal Cord Injury
name: Benita Kuni, Dr. med., M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05184751: Incidence and Risk Factors of Early Onset Colorectal Cancer
Official title: Incidence and Risk Factors of Early Onset Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Neoplasms
Lead sponsor: Hospital Frydek-Mistek
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 18257
Sex: ALL
Minimum age (years): 4
Maximum age (years): 97
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all patients who were indicated for colonoscopic examination (all indications) in period january 2012 to the end of june 2021

Brief summary: Early onset colorectal cancer (cancer in person younger than 50 years) has increasing incidence last years. The aim of our study was to assess the real-life incidence of early onset colorectal cancer, advanced neoplasias (colorectal cancer and/or advanced adenoma) and all neoplastic lesions in total in a single non-university endoscopic center.

Detailed description: The investigators retrospectively assessed the incidence of all neoplastic lesions, advanced neoplasias and colorectal cancer in population under 50 years of age compared to population 50 years and older. The investigators collected the data from all colonoscopic examinations performed in non-university hospital Frydek-Mistek from January 2012 to the end of June 2021.

Eligibility criteria: Inclusion Criteria: all patient who underwent colonoscopic examination clear indication for colonoscopy

Exclusion Criteria: not able to underwent colonoscopy

Primary outcomes:
measure: incidence of early onset colorectal neoplasias, risk factors
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Frydek-Mistek
name: Ivana Mikoviny Kajzrlikova
role: PRINCIPAL_INVESTIGATOR
References: