louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00263952: Efficacy and Safety of a Purified Standardised Bee Venom Preparation
Official title: Immunotherapy of Bee Venom Allergy: Evaluation of a New Purified Bee Venom Preparation in Comparison With Already Published Studies.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bee Venom Allergy
Keywords: Bee venom allergy
Specific immunotherapy
Lead sponsor: Allergopharma GmbH & Co. KG
Sponsor class: INDUSTRY
First posted: 2005-12-12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The trial is performed to assess efficacy and safety of a purified standardised bee venom preparation in bee venom allergy


Eligibility criteria: Inclusion Criteria:

* History of bee venom allergy,
* Positive RAST for bee venom,
* Positive skin prick test for bee venom

Exclusion Criteria:

* Serious chronic diseases

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Reinbek
country: Germany
facility: Allergopharma GmbH & Co. KG
Study officials:
name: Annemie Narkus, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02637752: Nutrition and Physical Activity Counselling
Official title: Efficacy of Nutrition and Physical Activity Counselling for Pre-adolescent Children in a Dental Setting: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Keywords: Pediatric Obesity
Body Mass Index
Dentistry
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2015-12-22
Enrollment: 168
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Background: Childhood obesity imposes a great burden on the healthcare system. Given the increased frequency of dental compared to medical visits during childhood, dentists may be in an ideal position to recognize patients at risk of developing obesity. This randomized clinical trial explored the efficacy of a brief nutrition and physical activity counseling for healthy weight 6 to11 year-old children in a university-based pediatric dental clinic.

Methods: 168 children, 6-11 year old, were allocated to test and control groups and their Body Mass index (BMI) were recorded. Their parents/caregivers completed a questionnaire regarding their child's nutrition, physical activity and screen time. The parents/caregivers of the test group then received a brief counseling session that encouraged an increase in children's physical activity, and a decrease in sugar-sweetened beverages and screen time. Data, collected at baseline and follow-up session (within 6-12 months) were analyzed using general linear regression, adjusting for age, gender, socio-demographic characteristics, education, labour force, income and awareness of school nutrition policy (P≤ 0.05).


Eligibility criteria: Inclusion Criteria:

* healthy
* 6 to 11 years old

Exclusion Criteria:

* Younger or older children
* those with systemic diseases (such as diabetes, cardiac problems, dyslipidemia, elevated cholesterol, obstructive sleep apnea, stroke, fatty liver disease, osteoarthritis, orthopedic problems and any forms of cancer)
* Children and their accompanying parents or caregivers (hereafter, caregivers) unable to communicate in English
* if caregivers were unreachable after three attempts by phone

Primary outcomes:
measure: Body Mass Index (BMI)
timeFrame: 6-12 months from the baseline
Secondary outcomes:
measure: physical activity (hrs/day)
timeFrame: 6-12 months
measure: screen time (hrs/day)
timeFrame: 6-12 months
measure: number of sugar-sweetened beverages consumed per day
timeFrame: 6-12 months
Other outcomes:
Locations:
Study officials:
affiliation: Assistant Professor
name: Amir Azarpazhooh, DDS MSc PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Azarpazhooh A, Sekhavat A, Sigal MJ. Validity of a simplified screening instrument for assessing overweight children in a dental setting: a cross sectional study. BMC Pediatr. 2017 Feb 17;17(1):56. doi: 10.1186/s12887-017-0808-x.
Clinical trial NCT00418652: Interruption of Dorsal Visual Stream Using TMS
Official title: Interruption of Dorsal Visual Stream Using TMS in Normal Controls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Normal Controls
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-01-05
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Trans Cranial Magnetic Stimulation (TMS) over dorsal visual system will disturb the ability to identify objects with decreased level of fragmentation

Detailed description: The participants performed two tasks under three different TMS conditions: no TMS, 10Hz TMS for over the dorsal stream (PO3 EEG site) or over the vertex.

First they performed a perceptual closure task which asked them to identify an object in a series of six progressively less degraded pictures.

Then, they also performed a control task previously shown not to be mediated by the LOC and not to be impaired in schizophrenia: The perception of illusory contours.

Eligibility criteria: Inclusion Criteria:

* Normal controls

Exclusion Criteria:

* neurological, ophthalmological or psychiatric problems
* family history of schizophrenia
* left handed

Primary outcomes:
measure: Results of the study assignments performed by the participants during the study.
timeFrame: The participants performed the tasks once during their study visit
Secondary outcomes:
Other outcomes:
Locations:
city: Tel-hashomer
country: Israel
facility: Psychiatry Clinic - Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Revital Amiaz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00249652: Transplant and Addiction Project (TAP) - 1
Official title: Drug Treatment for Transplant Candidates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: End Stage Liver Disease
End Stage Renal Disease
Substance-Related Disorders
Keywords: End stage liver disease
End stage renal disease
Substance-Related Disorders
Lead sponsor: St. Luke's-Roosevelt Hospital Center
Sponsor class: OTHER
First posted: 2005-11-07
Enrollment: 41
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 test a novel distance-based (telephone) intervention to help transplant candidates with current or recent substance abuse to stay "clean and sober" both prior and following transplant surgery.

Detailed description: Participants who need a liver or renal transplant and who are ineligible due to current or recent (past 6 months) alcohol and/or other drug abuse are being recruited from the transplant programs at St. Luke's-Roosevelt Hospital Center (renal), Columbia Presbyterian Hospital (renal/liver) and Virginia Commonwealth University Medical Center (liver). Baseline and follow-up computer-assisted assessments and structured clinical interviews along with collection of biological samples (urine, hair) will occur in the transplant clinics; however, phone counseling sessions originate at St. Luke's. Participants are randomly assigned to one of two treatments: (1) usual care (no phone counseling) or (2) usual care + counseling. The telephone counseling sessions are designed to help participants become motivated to remain abstinent and improve other health behaviors such as sleep or stress management.

Eligibility criteria: Inclusion Criteria:

* End stage liver or renal disease
* Having used drugs or alcohol during the past 6 months
* Turned down for transplant due to current or recent substance use
* Access to telephone

Exclusion Criteria:

* Psychotic or other unstable serious psychiatric disorders that preclude full, active participation
* Moderate to severe hepatic encephalopathy
* Non-English speaking

Primary outcomes:
measure: Abstinence
timeFrame: 3 month time frame
Secondary outcomes:
measure: Stage of Change, illness response, psychological stress
timeFrame: 3 month time frame
Other outcomes:
Locations:
city: New York
country: United States
facility: Behavioral Science Research Unit
state: New York
city: New York
country: United States
facility: Renal & Islet Transplant, Center for Liver Disease
state: New York
city: Richmond
country: United States
facility: Liver Transplant Program
state: Virginia
Study officials:
affiliation: St. Luke's Roosevelt Hosp Cntr (New York)
name: Deborah Haller
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wagner CC, Haller DL, Olbrisch ME. Relapse prevention treatment for liver transplant patients. J Clin Psychol Med Settings. 1996 Dec;3(4):387-98. doi: 10.1007/BF01994021.
citation: Presented at the Ninth Annual International Liver Transplantation Society Congress, Barcelona, Spain, June 2003.
Clinical trial NCT04880252: Neuropsychological Indicators of SCD Progression
Official title: In Individuals With Subjective Cognitive Decline, Age, Memory and Action Speed Scores at Baseline Predict Progression to Cognitive Impairment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Biomarkers
Cognitive Assessment
Cognitive Decline
Neurocognitive Disorders
Neurodegenerative Diseases
Subjective Cognitive Decline
Keywords: Biomarkers
Cognitive assessment
Cognitive decline
Neurocognitive disorders
Neurodegenerative diseases
Neuropsychological assessment
Risk of progression
Subjective cognitive decline
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2021-05-10
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients consulting for SCD at a university medical center's memory center (Amiens, France) and who had undergone three or more neuropsychological assessments at least 6 months apart.

Brief summary: Some patients with subjective cognitive decline (SCD) progress to neurocognitive disorders (NCD), whereas others remain stable; however, the neuropsychological determinants of this progression have not been identified. The investigators objective was to examine baseline neuropsychological indicators that could discriminate between people in whom the SCD progressed to a mild or major NCD and people in whom the SCD remained stable.

The investigators retrospectively included patients consulting for SCD at a university medical center's memory center (Amiens, France) and who had undergone three or more neuropsychological assessments at least 6 months apart. The relationship between domain-specific scores and the global cognitive score (GCS, as a function of final status (stable SCD vs. progression toward a mild or major NCD)) was examined using a generalized linear mixed model.


Eligibility criteria: Inclusion Criteria:

* patients who had been referred to the memory center at Amiens University Medical Center (Amiens, France).
* patients who had undergone three neuropsychological assessments at least 6 months apart, from 2005
* patients who met the criteria for SCD.

Exclusion Criteria:

* patients who didn't meet the criteria for SCD

Primary outcomes:
measure: Variation of neuropsychological indicators (global congnitive score) between NCD et SCD patients
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
citation: Perron A, Roussel M, Wannepain-Despretz S, Barbay M, Devendeville A, Godefroy O, Andriuta D. In Individuals With Subjective Cognitive Decline, Age, Memory and Speed Scores at Baseline Predict Progression to Cognitive Impairment. Alzheimer Dis Assoc Disord. 2022 Oct-Dec 01;36(4):359-361. doi: 10.1097/WAD.0000000000000520. Epub 2022 Jul 19.
Clinical trial NCT01480752: Reduction of Post-operative Endodontic Pain
Official title: the Effect of Intraligamentary Injection of Lornoxicam on the Intensity of Post-operative Endodontic Pain in the Tooth With Symptomatic Irreversible Pulpitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Post Operative Endodontic Pain
Keywords: In the patients with symptomatic Irreversible Pulpitis
Lead sponsor: Islamic Azad University, Sanandaj
Sponsor class: OTHER
First posted: 2011-11-29
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To determine the effect of intraligamentary injection of Lornoxicam on the intensity of post-operative endodontic pain in the tooth with symptomatic irreversible pulpitis.

Detailed description: sixty qualified samples (initial estimate which will be come more accurate after the pilot study on 6 patients) will be divided randomly in three groups which all of them will have an inferior Alveolar injection and before the beginning of the treatment the primary group will receive an injection of 0.4 mL ( 0.2 mL in mesio buccal and 0.2 mL in disto buccal) of Lornoxicam and the second group will be injected with 0.4 mL of normal saline( 0.2 mL in mesio buccal and 0.2 mL in disto buccal) ,in third group we will only pretend the injection but actually there is no substance injected ,making the patient believe that there was an injection . Then the patients' pain will be evaluated with visual Analogue Scale analysis (VAS) 0-170 mm in time intervals of 6, 12, 24 and 48 hours after the treatment.

Eligibility criteria: Inclusion Criteria:

* healthy (ASA I, II);
* Patients with first or second mandibular molars who need endodontic treatment;
* Vital tooth without a history of past endodontic treatment;
* Patients with clinical evidence of irreversible Pulpits with moderate to severe pain;
* Patients without pre apical lesion and periodontal ligament enlargement more than 0.75-1mm on the x-ray images;
* Patients in the age group of 18-65 years old

Exclusion Criteria:

* Pregnant or nursing;
* necrotic tooth;
* Patients with allergy or contraindication toward non-opioid or opioid painkillers such as aspirin or NSAIDs;
* People who have a history of acute peptic ulcer, during the past 12 months;
* People who have bleeding problems or have been taking anticoagulant drugs over the past month;
* Patients who have taken opioid or non opioid or steroid pain killers, antidepressants or sedative drugs.

Primary outcomes:
measure: Post operative endodontic's pain
timeFrame: 6,12,24,48 hours after drug's injection
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Dental School of Azad University
Study officials:
References:
Clinical trial NCT00995852: Unilateral Versus Bilateral Endoscopic Lung Volume Reduction A Comparative Case Study
Official title: Unilateral vs. Bilateral IBV Placement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Pulmonary Emphysema
Keywords: Endoscopic lung volume reduction
emphysema
COPD
Patients with bilateral heterogeneous pulmonary emphysema
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: Olympus Corporation of the Americas
First posted: 2009-10-15
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with bilateral heterogeneous pulmonary emphysema benefit to differing degrees from unilateral ELVR with complete lobe closure in comparison with incomplete bilateral treatment.

Detailed description: Patient enrolment and data acquisition is to be carried out on a prospective basis. It is planned to enrol a total of 20 patients with bilateral heterogeneous pulmonary emphysema. All patients will undergo treatment at one study centre in Heidelberg. Patients will be considered for both unilateral and bilateral treatment with intrabronchial valves (IBV) on the basis of their emphysema distribution. Patients will be randomised to two treatment arms. 10 patients receive unilateral or bilateral treatment in each case.

Eligibility criteria: Inclusion Criteria:

* age \> 40 inhomogeneous emphysema FEV1 between 20-40% DLCO between 20-40% 6MWT \> 150 m

Exclusion Criteria:

* pregnant homogeneous disease FEV1 \< 20%

Primary outcomes:
measure: Improvement in pulmonary function (FEV1) 6-minute walking test
timeFrame: 3 months
Secondary outcomes:
measure: Number of major complications(SAE)
timeFrame: 3 months
measure: Evaluation of the IBV migration rate
timeFrame: 3 months
measure: Average changes in quality of life (SGRQ)
timeFrame: 3 months
measure: Average changes in pulmonary function (FEV1, IVC, RV, TLC, RV/TLC)
timeFrame: 3 months
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Thoraxklinik Heidelberg
Study officials:
affiliation: Heidelberg University
name: Felix JF Herth, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Venuta F, Rendina EA, Coloni GF. Endobronchial treatment of emphysema with one-way valves. Thorac Surg Clin. 2009 May;19(2):255-60, x. doi: 10.1016/j.thorsurg.2009.04.002.
citation: Chan KM, Martinez FJ, Chang AC. Nonmedical therapy for chronic obstructive pulmonary disease. Proc Am Thorac Soc. 2009 Jan 15;6(1):137-45. doi: 10.1513/pats.200809-114GO.
citation: Ingenito EP, Wood DE, Utz JP. Bronchoscopic lung volume reduction in severe emphysema. Proc Am Thorac Soc. 2008 May 1;5(4):454-60. doi: 10.1513/pats.200707-085ET.
citation: Eberhardt R, Gompelmann D, Schuhmann M, Reinhardt H, Ernst A, Heussel CP, Herth FJF. Complete unilateral vs partial bilateral endoscopic lung volume reduction in patients with bilateral lung emphysema. Chest. 2012 Oct;142(4):900-908. doi: 10.1378/chest.11-2886.
Clinical trial NCT05947552: Serum Ferritin In CKD Patients Serum Ferritin
Official title: Variability of Serum Ferritin in CKD Patients and How These Variables May Affect the Treatment Decisions With Iron
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Kidney Diseases
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-07-17
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ALL CKD patients who are not dialysis Stage 3 to 5

Brief summary: Variability of serum ferritin in CKD patients and how these variables may affect the treatment decisions with iron supplements

Detailed description: Serum ferritin has a wide range Variability in CKD patients this makes the use of serum ferritin as an indicator of iron deficiency is limited and mostly CKD is secondary to inflammation so serum ferritin as ferritin is an acute phase reactants so it will be very high in CKD patients ,

Eligibility criteria: Inclusion Criteria:

* ALL CKD patients stage 3 to 5 not on dialysis

Exclusion Criteria:

* inflammatory chronic diseases IDA Autoimmune disorders Liver diseases Malignancy Infections

Primary outcomes:
measure: to assess the role of serum ferritin in CKD patients din in CKD patients and how these variability
timeFrame: Recurring
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
affiliation: Assiut University
name: Hawaid Ab Nafady, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03898752: Is Oxidative Stress in Semen Reduced by Lifestyle Intervention
Official title: Is Oxidative Stress in Semen Reduced by Lifestyle Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oligospermia
Lead sponsor: Regionshospitalet Viborg, Skive
Sponsor class: OTHER
First posted: 2019-04-02
Enrollment: 31
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All men with DFI \>15 (SCSA method) are assigned to life-style intervention.
Primary purpose: PREVENTION

Brief summary: In this study we aim to investigate whether a 3-month life-style intervention would reduce oxidative stress (OS) in semen in men of infertile couples attending IVF-treatment. Men with a DFI above 15% (SCSA method) are recruited for intervention with a 3-month follow-up.

It is hypothesized that men who also have a OS above 1.34 using a novel OS diagnostic method (MiOXSYS) respond better to antioxidant treatment with a change in OS and DFI. The primary outcome is the change in OS following the intervention. Secondary outcomes are morphological semen parameters and DNA fragmentation index.


Eligibility criteria: Inclusion Criteria:

* DFI\>15
* Attending IVF treatment for unknown or male factor infertility.

Exclusion Criteria:

* Genetic diseases
* Azospermia

Primary outcomes:
measure: Oxidative stress
timeFrame: 3 months
Secondary outcomes:
measure: Semen quality
timeFrame: 3 months
measure: DNA fragmentation index
timeFrame: 3 months
Other outcomes:
Locations:
city: Skive
country: Denmark
facility: The Fertility Clinic Skive
state: Central Denmark Region
Study officials:
References:
citation: Humaidan P, Haahr T, Povlsen BB, Kofod L, Laursen RJ, Alsbjerg B, Elbaek HO, Esteves SC. The combined effect of lifestyle intervention and antioxidant therapy on sperm DNA fragmentation and seminal oxidative stress in IVF patients: a pilot study. Int Braz J Urol. 2022 Jan-Feb;48(1):131-156. doi: 10.1590/S1677-5538.IBJU.2021.0604.
Clinical trial NCT01302652: Effect of Growth Hormone (GH) on Cardiac Echos in GH Deficient Patients After Acromegaly Treatment
Official title: Effects of Physiologic Growth Hormone Administration on Echocardiographic Parameters in Subjects With Growth Hormone Deficiency Following Cure of Acromegaly
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acromegaly
Keywords: acromegaly
growth hormone
growth hormone deficiency
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2011-02-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women between age 18-75 who have developed growth hormone deficiency after history of acromegaly with biochemical cure.

Brief summary: The purpose of this research study is to study the effects of growth hormone (GH) replacement on the heart. The investigators will study these effects in people who have been cured of acromegaly and then have developed growth hormone deficiency (GHD, not enough growth hormone).


Eligibility criteria: Inclusion Criteria:

* age 18-75
* history of acromegaly with biochemical cure
* growth hormone deficiency

Exclusion Criteria:

* untreated thyroid disease within the past 3 months
* untreated adrenal insufficiency within the past 3 months
* uncontrolled hypertension
* congestive heart failure
* gonadal steroid therapy within the past 3 months
* pregnancy or nursing

Primary outcomes:
measure: Change from Baseline in Echocardiographic Findings at One Year
timeFrame: baseline and one year
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Karen K Miller, MD
role: PRINCIPAL_INVESTIGATOR
References: