louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02621736: Copeptin for Prediction of Treatment Response in Children With Monosymptomatic Nocturnal Enuresis (MEN).
Official title: Copeptin for Prediction of Treatment Response in Children With Monosymptomatic Nocturnal Enuresis (MEN).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nocturnal Enuresis
Keywords: children
desmopressin
copeptin
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: University Children's Hospital Basel
First posted: 2015-12-03
Enrollment: 28
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children at the Age of 5-16 years with monosymptomatic enuresis nocturna

Brief summary: Monosymptomatic nocturnal enuresis (MEN) is a common problem in children, affecting 7-10% of all 7 year olds. MEN is often leading to psychosocial problems because of its burden and stigmatism.

The only available medical treatment option is the vasopressin analogum Desmopressin®. However, according to the literature, only one third of patients shows a good treatment response, defined as more than 90% of reduced bed wetting. Furthermore, treatment with Desmopressin® may lead to psychosocial problems, high costs and potentially dangerous side effects like water intoxication and hypertension.

Copeptin, mirroring arginine vasopressin (AVP), has been shown to be significantly lower in patients with MEN compared to controls and lower in patients with severe bed wetting compared to patients with only slight bed wetting.


Eligibility criteria: Inclusion Criteria:

* Children at the age between 5 and 16 years
* Diagnosis of monosymptomatic nocturnal enuresis
* Completion of uroflowmetry and bladder sonography if possible
* Completion of home recording charts of bed wetting episodes if possible
* Willingness to use Desmopressin® treatment

Exclusion Criteria:

* Children with daytime enuresis
* Children with lower urinary tract symptoms and infection
* Children with structural abnormalities of the urinary tract
* Children with chronic illness, esp. renal failure, hypertension, congenital heart disease, diabetes mellitus and diabetes insipidus.

Primary outcomes:
measure: Change of copeptin at baseline and after 28 days during routine desmopressin therapy
timeFrame: morning and evening copeptin levels at baseline day 0 before routine desmopressin therapy and day 28 during routine desmopressin therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
state: Basel-Stadt
Study officials:
affiliation: University Hospital Basel, Department of Endocrinology, Diabetes and Metabolism
name: Mirjam Christ-Crain, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05406336: Machine Learning to Reduce Hypertension Treatment Clinical Inertia
Official title: Machine Learning to Reduce Hypertension Treatment Clinical Inertia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: Uncontrolled blood pressure
Antihypertensive medication
Hypertension treatment
Clinical inertia
Machine learning
Lead sponsor: Temple University
Sponsor class: OTHER
First posted: 2022-06-06
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Among individuals with an uncontrolled BP at the current visit, the objective of this study is to compare clinical management of hypertension with and without information from a machine learning algorithm on whether a patient will have uncontrolled blood pressure at their next follow up visit through a case-vignette study.

Detailed description: Among adults with uncontrolled blood pressure (BP) at a clinic visit, clinical inertia is common. Clinical inertia is defined as a failure of providers to initiate or intensify treatment (i.e., adding medication or increasing dosage) when guidelines indicate doing so. Prior studies report that clinicians intensify antihypertensive medication treatment in less than 20% of visits where intensification would have been clinically recommended. Thus, patients who have uncontrolled BP may not receive timely therapy to control their BP. To address this issue, the investigators will use a randomized design to test the hypothesis that clinicians will be more likely to intensify the hypertensive regimen and/or assess nonadherence for patients with uncontrolled BP at the current visit when presented with information that a patient is predicted to have uncontrolled BP at the next visit by a machine learning algorithm.

Eligibility criteria: Inclusion Criteria: practicing primary care clinicians who see patients (i.e., internal medicine, family medicine, attending physicians, nurse practitioners) will be eligible to participate -

Exclusion Criteria:

-

Primary outcomes:
measure: Vignette #1 - antihypertensive medication treatment intensification
timeFrame: Immediately after clinical vignette
measure: Vignette #2 - antihypertensive medication treatment intensification
timeFrame: Immediately after clinical vignette
measure: Vignette #3 - antihypertensive medication treatment intensification
timeFrame: Immediately after clinical vignette
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Alabama at Birmingham
name: Gabriel Tajeu, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04502836: Evaluation of the Correlation Between Psychological Intervention, Including Providing Knowledge and Tools for Problems Solving, and the Anxiety Level of Female Patients Arriving to ACTH LRH Test - Pilot Study
Official title: Evaluation of the Correlation Between Psychological Intervention, Including Providing Knowledge and Tools for Problems Solving, and the Anxiety Level of Female Patients Arriving to ACTH LRH Test - Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Precocious Puberty
Keywords: ACTH LRH Test
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2020-08-06
Enrollment: 27
Sex: FEMALE
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Over 20% of the population is reporting on "white coat syndrome", manifested as anxiety symptoms and elevated BP during interaction with medical staff. It is estimated that, throughout the life span of children, approximately 15-20% will suffer from some form of a trauma relating to an interaction with health provider. The proposed study aims is to evaluate the correlation between a single preliminary psychological intervention, including providing knowledge and tools for problems solving, and the anxiety level in female patients arriving to Adrenocorticotropic Hormone (ACTH) and Lutenising Releasing Hormone (LRH) test in comparison to the anxiety in patients arriving to the same test without psychological intervention. 20 female patients arriving to ACTH LRH test for puberty stage assessment (performed as part of routine medical care) will be recruited to the study and will be randomized to one of 2 groups. Participants in the intervention group (10 patients) will be required to arrive with their parents an hour prior to the test and will receive a preliminary psychological intervention. The control group will arrive to the ACTH LRH test on the scheduled time and will not receive psychological intervention


Eligibility criteria: Inclusion Criteria:

* Girls referred to ACTH LRH or LRH test
* Age 7-12 years old
* Ability to answer questionnaire independently (hebrew language only)

Exclusion Criteria:

* Mental disability
* Girls who were referred to the test in purpose of evaluation of the pituitary adrenal axis after prolong steroids therapy.
* Girls with chronic disease that required frequent hospitalization (over 4 times per year)

Primary outcomes:
measure: Anxiety Questionnaire
timeFrame: Baseline (Visit 1), At the end of the ACTH LRH test, 2 hours
Secondary outcomes:
measure: Parents Treatment Satisfaction Questionnaire
timeFrame: Baseline (Visit 1), At the end of the ACTH LRH test, 2 hours
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Schneider Children's Medical Center of Israel
Study officials:
affiliation: Schneider Children's Medical Center, Israel
name: Moshe Phillip, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02633436: Research on the Role of SLC1A5 in the Development of Esophageal Cancer
Official title: Research on the Role of the Amino Acid Transporter SLC1A5 in the Development of Esophageal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Esophageal Cancer
Amino Acid Transport Disorder
Keywords: esophageal cancer
SLC1A5
Lead sponsor: Fourth Affiliated Hospital of Guangxi Medical University
Sponsor class: OTHER
Collaborators: name: Liuzhou Maternity and Child Healthcare Hospital
First posted: 2015-12-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with histologically proven esophageal cancer

Brief summary: To explore the significance of Solute Carrier Family 1 Member 5 (SLC1A5) in the occurrence of esophageal cancer, by comparing the expression of SLC1A5 between esophageal cancer tissues and adjacent tissues.

Detailed description: This will be an observational study. The investigators will aim to enroll 100 male and female adult patients (aged 18 years and over) of all ethnicities/races, who have been referred to the Fourth Affiliated Hospital of Guangxi Medical University for esophageal cancer.

The investigators will be using a standardized data collection form. This is an observational study in which standard of care will be practiced and the patients are not placed at additional risk from participating in this study. However, as the investigators are collecting data prospectively, all participants will sign consent. An attempt will be made to see if there is a correlation between the expression of SLC1A5 with esophageal cancer.

Eligibility criteria: Inclusion Criteria:

1. Patients with histologically proven esophageal cancer;
2. Age ≥18 years;
3. All patients must sign consent forms voluntarily;

Exclusion Criteria:

1. Inability to obtain histologic proof of malignancy.
2. Age \<18 years;

Primary outcomes:
measure: optical density (ODs) of each slice by immunohistochemistry assay
timeFrame: within one year (plus or minus 1 month) after surgery
Secondary outcomes:
measure: SLC1A5 expression detected by WesternBlot
timeFrame: within one year (plus or minus 1 month) after surgery
Other outcomes:
Locations:
city: Liuzhou
country: China
facility: Liuzhou Maternity and Child Healthcare Hospital
state: Guangxi
city: Liuzhou
country: China
facility: The Fourth Affiliated Hospital of Guangxi Medical University
state: Guangxi
Study officials:
affiliation: Guangxi Medical University Institutional Review Board
name: Xiangcheng Wei
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00050336: Study of Lonafarnib in Combination With Paclitaxel and Carboplatin in Patients With Non-Small Cell Lung Cancer (Study P01901)(TERMINATED)
Official title: A Phase 3 Randomized Study of Lonafarnib in Combination With Paclitaxel and Carboplatin vs. Placebo in Combination With Paclitaxel and Carboplatin in Patients With Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Carcinoma, Non-small-cell Lung
Metastases, Neoplasm
Keywords: Stage 3b or 4 (metastatic) non-small cell lung cancer
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2002-12-05
Enrollment: 702
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the overall survival of patients diagnosed with Stage 3b or 4 non-small cell lung cancer (NSCLC) treated with an oral Farnesyl Protein Transferase Inhibitor (Lonafarnib/SCH 66336) in combination with paclitaxel and carboplatin with that of patients treated with placebo in combination with paclitaxel and carboplatin.


Eligibility criteria: Inclusion Criteria:

* Male or female
* Histologically or cytologically 3b or 4 (metastatic) non-small cell lung cancer. Patients must meet any subcriteria as detailed in the protocol.
* Age greater than or equal to 18 years old
* ECOG performance status of 0 to 1
* Prior diagnosis of brain metastases from NSCLC eligible provided that the brain metastases have been adequately treated, patient is neurologically stable and no new or progressive brain metastases identified.
* Meets protocol requirements for specified laboratory values
* Written informed consent
* Appropriate use of effective contraception if of childbearing potential
* Prior basal cell carcinoma or carcinoma in-situ of the cervix are eligible provided they have been treated with no evidence of disease

Exclusion Criteria:

* Prior chemotherapy for any stage of NSCLC
* Prior surgery or radiation therapy within the last 2 weeks or incomplete recovery from prior procedures or therapy
* Concurrent treatment or treatment within the last 2 years for any other malignancy
* Grade 2 or greater nausea or Grade 1 or greater vomiting (despite antiemetic medication)
* Medical conditions that would interfere with taking oral medications
* Patients with bone metastases as the only site of disease
* Pregnant or nursing women
* Known HIV positivity or AIDS-related illness
* Patients with significant QTc prolongation at baseline

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02429336: Characteristics of Women With Reproductive Concerns
Official title: Clinical Characteristics of Women Presenting to the Reproductive Endocrinology Clinic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endocrine Disorders of Female Reproductive System
Lead sponsor: University of Tennessee
Sponsor class: OTHER
First posted: 2015-04-29
Enrollment: 194
Sex: FEMALE
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Population: All patients presenting to the reproductive endocrinology clinic.

Brief summary: The purpose of this study is to collect data that will be generated during an office visit. The data will be gathered and analyzed in research studies that will help with the investigators understanding of various medical conditions.

About 200 subjects will be participating in this study. Participation in this study will not require a patient's time or presence. The medical information contained in a patient's chart from the office visit, including the results of any tests that were ordered at that time, will be transferred to an anonymous database and analyzed together with data from other patients who have similar condition/s.

No follow-up information will be collected. The following information will be collected from a patient's medical record: the medical history and a list of the current medications.

Detailed description: Purpose: To collect the characteristics of patients presenting to the reproductive endocrinology clinic.

Rationale: Patients' characteristics will be analyzed as part of clinical research studies and may help in understanding the causes of their condition.

Eligibility criteria: Inclusion Criteria:

* females of childbearing potential experiencing reproductive endocrinology related problems

Exclusion Criteria:

* male or female not of childbearing potential

Primary outcomes:
measure: Data collection from patients' charts.
timeFrame: up to 1 year from the time of signing the informed consent for data collection
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Regional One Health Ob-Gyn Clinic
state: Tennessee
Study officials:
affiliation: Associate Professor, UTennessee Health Science Center
name: Laura Detti, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03072836: Study of Gut Microbiota in Crohn's Disease Patients Suffering From Spondylarthritis
Official title: Study of Gut Microbiota in Crohn's Disease Patients Suffering From Spondylarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Crohn Disease
Spondyloarthritis
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2017-03-07
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The FLORACROHN project aims to compare gut microbiota of patients suffering from Crohn's disease (CD) associated or not to spondylarthritis (SpA).

3 groups of patients will be analyzed: patients suffering from CD alone, patients suffering from SpA alone, patients suffering from CD and SpA.

Fecal microbiota will be determined by 16SRNA gene sequencing.


Eligibility criteria: Inclusion Criteria:

* Patients with Crohn's disease and axial spondyloarthritis according to the criteria below.

  * Patients with Crohn's disease (CT patients) diagnosed according to clinical, biological, radiological, endoscopic and / or histological criteria for 3 months. With diagnosis of spondyloarthritis exclusion on modified ASAS and / or New York criteria.
  * Patients with axial spondyloarthritis (SpA patients) diagnosed according to the modified ASAS and / or New York criteria with exclusion diagnosis of Crohn's disease.
* Patient with the capacity to give free and informed consent.

Exclusion Criteria:

Antecedent of colonic resection

* Antibiotic or colonic colonoscopy preparation in the 8 weeks prior to stool collection (against temporary indication = collection possible before colic preparation or on the first saddle after the start of the colic preparation).
* Ostomy at time of collection
* BMI\> 30
* extreme diet
* unbalanced diabetes
* Patient under guardianship, under curatorship or under safeguard of justice

Primary outcomes:
measure: Microbiota analysis
timeFrame: 6 months after last patient inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Vandoeuvre les Nancy
country: France
facility: CHRU de Nancy
Study officials:
References:
Clinical trial NCT06256536: A Study of GZR18 Injection in Chinese Obese/Overweight Patients
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase Ib/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of GZR18 Injection in Chinese Obese/Overweight Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Obesity
Overweight
Lead sponsor: Gan and Lee Pharmaceuticals, USA
Sponsor class: INDUSTRY
First posted: 2024-02-13
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 study was a multicenter, randomized, double-blind, placebo-controlled phase Ib/IIa clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy of GZR18 injection in Chinese adult obese/overweight patients. This study is divided into Part A and Part B, which are to be conducted simultaneously.


Eligibility criteria: Inclusion Criteria:

* 1. Male or female aged 18-65 years (inclusive);

  2. Obese subjects: BMI ≥ 28.0 kg/m2; or overweight subjects: 24.0 ≤ BMI \< 28.0 kg/m2 with at least one comorbidity;

  3. Able to understand the procedures and methods in this study; willing to complete the study in strict accordance with the clinical study protocol and sign the ICF voluntarily.

Exclusion Criteria:

* 1. Suspicion that the subject may be allergic to any study drug or ingredient or congener from the investigator.

  2. Subjects with body weight change \> 5.0% for any reason (diet, exercise, etc.) within 12 weeks prior to screening.

  3. Heart rate \< 50 beats/min or \> 100 beats/min on 12-lead ECG at screening.

  4. Presence of the following clinically significant 12-lead ECG abnormalities at screening.

  5. Alcohol abuse within 6 months prior to screening, or reluctance to stop alcohol abuse throughout the study, or a positive breath alcohol test result at screening.

Primary outcomes:
measure: Incidence of adverse events and serious adverse events
timeFrame: 38 weeks
measure: Changes in weight from baseline to the end of treatment
timeFrame: 35 weeks
Secondary outcomes:
measure: trough concentrations following consecutive doses
timeFrame: 35 weeks
measure: Changes in Body mass index (BMI) from baseline to the end of treatment
timeFrame: 35 weeks
measure: Changes in Percentage of reduction in weight (%) from baseline to the end of treatment
timeFrame: 35 weeks
measure: Changes in Waist circumference from baseline to the end of treatment
timeFrame: 35 weeks
measure: Proportion of subjects with ≥5% reduction in body weight from baseline.
timeFrame: 35 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Gan & Lee Pharmaceuticals Co., Ltd
Study officials:
affiliation: Gan & Lee Pharmaceuticals.
name: Liyuan Zhao, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT05321836: GLUCOSAMINE/CHONDROITIN and PHYSICAL THERAPY EFFECTS ON OLDER POPULATION WITH KNEE OSTEOARTHRITIS
Official title: EFFECTS OF COMBINED GLUCOSAMINE/CHONDROITIN WITH STRUCTURED PHYSICAL THERAPY PROGRAM ON KNEE OSTEOARTHRITIS: A RANDOMIZED CONTROL TRAIL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: OA, Chondratin sulfate, glucosamine, Physiotherapy
Lead sponsor: Neuro Counsel Hospital, Pakistan
Sponsor class: OTHER
First posted: 2022-04-11
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two groups
Primary purpose: TREATMENT

Brief summary: to see the effect of glucosamine chondratin sulfate with and without physiotherapy in knee osteoarthritis

Detailed description: it is a randomized control trail to evaluate the effectiveness of glucosamine chondratin sulfate alone and in combination with physiotherapy on knee osteoarthritis

Eligibility criteria: Inclusion Criteria:

* age \> 50 years with radiographic evidence of mild to moderate knee OA (Kellgren Lawrence grade II \& III 20) who met the ACR clinical 21,
* radiographic classification criteria or confirmation of mild to moderate radiographic evidence of knee OA from a personal physician
* not currently participating in another intervention study

Exclusion Criteria:

* dementia (Mini-Mental State Examination \[MMSE\]\< 24)
* active cancer other than skin cancer
* anemia (participants with an hematocrit (HCT)\< 32 (or a hemoglobin below10) were excluded due to possible inability to adequately exercise or the increased potential for increased risk for serious adverse cardiovascular events)
* severe renal insufficiency (serum creat\> 2)
* hepatic disease

Primary outcomes:
measure: WOMAC
timeFrame: 6 months
Secondary outcomes:
measure: SF-36
timeFrame: 6 months
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Muhammad Umar
state: Punjab
Study officials:
affiliation: the physiotherapy clinic
name: MUHAMMAD UMAR
role: PRINCIPAL_INVESTIGATOR
References: