louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06081023: Development and Feasibility of Psycho-Educational Weight Reduction Program for Young Adults
Official title: Development and Feasibility of Psycho-Educational Weight Reduction Program for Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotional Eating
Obesity
Keywords: Psycho-educational weight reduction program
Lead sponsor: Health Education Research Foundation (HERF)
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 14
Sex: ALL
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Two groups i-e control and experimental. The experimental group was provided with treatment while the control group was only provided with behavioral relaxing techniques.
Primary purpose: SCREENING

Brief summary: The main aim of the study was to assess the efficacy of psycho-educational weight reduction program for reducing emotional eating and obesity

Detailed description: All participants who provide written informed consent will go through a screening process to evaluate their eligibility for study entrance after being briefed about the study and any potential risks. Individuals who met the eligibility requirements will then be randomly assigned to the control group and the experimental group.

Eligibility criteria: Inclusion Criteria:

* Individuals must be enrolled at a university.
* Based on World Health Organizations age range young adults were selected for the current study i-e 19 years to 35 years (WHO; 2019).

Exclusion Criteria:

* The young adults who diagnosed with any chronic health concern, either psychological or physical must not be included in the current study.
* The individuals who joined any kind of weight loss program or gym were also not included in the study.
* Individuals older than 35 were not included in the current study either.

Primary outcomes:
measure: Change from Baseline in Emotional Eating on Emotional Eating Scale (EES-25) after 12 weeks
timeFrame: Baseline and Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Nimra Anjum
state: Punjab
Study officials:
References:
Clinical trial NCT04979923: Efficacy of Nebulized Lidocaine, Salbutamol, and Beclomethasone Plus Salbutamol in the Covid-19 Patients With ARDS on Non-invasive Ventilation; Randomized Control Trial
Official title: Efficacy of Nebulized Lidocaine, Salbutamol, and Beclomethasone Plus Salbutamol in the Covid-19 Patients With ARDS on Non-invasive Ventilation; Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: COVID-19 Acute Respiratory Distress Syndrome
Lead sponsor: Sheikh Zayed Medical College
Sponsor class: OTHER_GOV
First posted: 2021-07-28
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The COVID-19, a pandemic as declare by WHO1, has a devastating impact on health and economic worldwide2. Literature suggests that acute respiratory distress syndrome (ARDS) develops over 20% of the infected individuals with Coivd-pneumonia3 along with other symptoms like fever followed by cough and dyspnea as well as chest pain in severe cases4. The current preventative strategies are non-specific10, and current interventions are predominantly supportive1. Recently, some studies have demonstrated anti-inflammatory actions for local anesthetics including lidocaine.


Eligibility criteria: Inclusion Criteria:

* Covid-19 positive
* Moderate to severe ARDS

Exclusion Criteria:

* patients with COPD or taking bronchodilators and steroids for chronic respiratory illnesses

Primary outcomes:
measure: Cough suppression
timeFrame: within five minutes of initiation of treatment it will be assessed
Secondary outcomes:
measure: correction of hypoxia
timeFrame: immediately before and after intervention
Other outcomes:
Locations:
city: Rahim Yar Khan
country: Pakistan
facility: Sheikh zayed medical college & hospital
state: Punjab
Study officials:
References:
Clinical trial NCT00036023: Chemotherapy Related Anemia in Patients With Non-Myeloid Malignancies
Official title: A Randomized, Open-Label, Dose-Timing Study of Darbepoetin Alfa Administered Once Every 3 Weeks (Q3W) by Subcutaneous (SC) Injection for Treatment of Anemia in Subjects With Non-Myeloid Malignancies Receiving Multicycle Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma
Breast Neoplasms
Lung Neoplasms
Multiple Myeloma
Chronic Lymphocytic Leukemia
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2002-05-08
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: Chemotherapy can often cause anemia in patients with cancer. Anemia is a low number of red blood cells. The symptoms of anemia may include fatigue, dizziness, headache, chest pain, and shortness of breath. Erythropoietin is a hormone made by the kidneys that signals the bone marrow to produce more red blood cells. Recombinant human erythropoietin has been produced in the laboratory and has the same effect as the hormone produced by the body. Use of recombinant human erythropoietin allows the body to produce more red blood cells, possibly eliminating or decreasing your symptoms and the need for a red blood cell transfusion. Recombinant human erythropoietin is FDA approved to treat anemia in cancer patients receiving chemotherapy. This clinical study is investigating the effectiveness of darbepoetin alfa for the treatment of anemia in patients with non-myeloid malignancies who are receiving chemotherapy every three weeks. Darbepoetin alfa is a recombinant erythropoietic protein that stimulates the production of red blood cells. This medication has not been approved to treat cancer patients with anemia, however it has been approved by the FDA to treat chronic renal failure patients with anemia.


Eligibility criteria: * Patients with non-myeloid malignancies \* Patients receiving at least 12 weeks of chemotherapy on a 3-week cycle schedule \* Patients with anemia (hgb \>/= 9.0 and \</= 11.0 g/dL)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Glaspy J, Henry D, Patel R, Tchekmedyian S, Applebaum S, Berdeaux D, Lloyd R, Berg R, Austin M, Rossi G; Darbepoetin Alfa 20010162 Study Group. Effects of chemotherapy on endogenous erythropoietin levels and the pharmacokinetics and erythropoietic response of darbepoetin alfa: a randomised clinical trial of synchronous versus asynchronous dosing of darbepoetin alfa. Eur J Cancer. 2005 May;41(8):1140-9. doi: 10.1016/j.ejca.2005.01.021. Epub 2005 Apr 8.
Clinical trial NCT04326023: Myelodysplastic Syndrome and Acute Myeloid Leukemia Related to PARP Inhibitors (MyeloRIB)
Official title: Myelodysplastic Syndrome and Acute Myeloid Leukemia Related to PARP Inhibitors in Cancer Patients : an Observational and Retrospective Study Using the WHO and the French Pharmacovigilance Databases (MyeloRIB)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2020-03-30
Enrollment: 178
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients treated with PARPi and experiencing MDS/AML.

Brief summary: Although PARP inhibitors (PARPi) have proved effective in treating many cancers, few patients receiving PARPi may experience rare but life-threatening adverse events such as myelodysplastic syndrome (MDS) and/or acute myeloid leukaemia (AML). Today, data about MDS/AML are scarce.

The objective was to investigate reports of MDS/AML adverse events related to PARPi, including olaparib, rucaparib, niraparib, talazoparib and veliparib using the World Health Organization (WHO) and the French pharmacovigilance databases.

Detailed description: Here, investigators use the World Health Organization (WHO) and the French database of individual safety case reports, to identify cases of MDS/AML related to PARPi.

Eligibility criteria: Inclusion Criteria:

* Case reported in the World Health Organization (WHO, also called VigiBase) or French database of individual safety case reports at the time of the extraction,
* Patients treated with at least 1 PARPi (with ATC classification system): olaparib (ATC L01XX46), niraparib (ATC L01XX54), rucaparib (ATC L01XX55), talazoparib (ATC L01XX60), veliparib (none).

Exclusion Criteria:

* Chronology not compatible between the PARPi and adverse event (MDS/AML)

Primary outcomes:
measure: MDS/AML reports related to PARPi (from WHO database).
timeFrame: From inception to May 3, 2020
measure: MDS/AML reports related to PARPi (from French database).
timeFrame: From inception to May 1, 2021
Secondary outcomes:
measure: Description of the median time to onset since first PARPi exposure.
timeFrame: From inception to May 3, 2020
measure: Description of the fatality rate.
timeFrame: From inception to May 3, 2020
measure: Description of patients who experienced co-reported adverse events.
timeFrame: From inception to May 3, 2020
Other outcomes:
Locations:
city: Caen
country: France
facility: Alexandre Joachim
state: Basse Normandie
Study officials:
References:
citation: Morice PM, Leary A, Dolladille C, Chretien B, Poulain L, Gonzalez-Martin A, Moore K, O'Reilly EM, Ray-Coquard I, Alexandre J. Myelodysplastic syndrome and acute myeloid leukaemia in patients treated with PARP inhibitors: a safety meta-analysis of randomised controlled trials and a retrospective study of the WHO pharmacovigilance database. Lancet Haematol. 2021 Feb;8(2):e122-e134. doi: 10.1016/S2352-3026(20)30360-4. Epub 2020 Dec 18.
Clinical trial NCT02688023: Neoadjuvant Triplet Chemotherapy Regimen in Patients With Resectable Colorectal Cancer
Official title: A Pilot Phase II Study of Triplet Chemotherapy Regimen in Neoadjuvant Chemotherapy of Patients With Resectable Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Colorectal Cancer
Keywords: 5-fluorouracil
Irinotecan
Oxaliplatin
Colorectal cancer
neoadjuvant
chemotherapy
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
Collaborators: name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
First posted: 2016-02-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Colorectal cancer is an aggressive malignancy with a poor overall outcome. The purpose of this study is to evaluate the feasibility, safety and efficacy of neoadjuvant oxaliplatin, irinotecan combined with 5-fluorouraci/leucovorin or S-1 or capecitabine in patients with resectable colorectal cancer.

Detailed description: This is a single arm, phase 2 study of neoadjuvant triplet chemotherapy regimen of oxaliplatin, irinotecan combined with 5-fluorouraci/leucovorin or S-1 or capecitabine in patients with resectable colorectal cancer.Fifty patients will be enrolled in this trial. The primary objective of this study is to determine the 3-year disease-free survival of the patients.

Eligibility criteria: Inclusion Criteria:

* histologically verified colorectal cancer
* clinical stage T4N0-2M0、cT1-3N2M0 or M1(liver metastases only)
* age: 18-70 years
* ECOG 0-2
* adequate bone marrow, liver, renal and cardiac function (no history of ischemic heart disease)
* no prior cancer and/or chemotherapy
* signed informed consent

Exclusion Criteria:

* patients with a history of prior malignancy
* pregnant or lactating patients
* known or suspected brain metastasis

Primary outcomes:
measure: 3-year disease-free survival
timeFrame: 5 years
Secondary outcomes:
measure: objective response rate
timeFrame: 2 years
measure: Surgical complete resection rate (R0)
timeFrame: 2 years
measure: overall survival
timeFrame: 6 years
measure: Number of participants with adverse events that are related to treatment
timeFrame: 2 years
measure: Number of participants with surgery complications
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: Cancer Hospital, CAMS
name: Jing Huang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03548623: Patient Preference in Blood Pressure Therapy
Official title: Patient Preference in Blood Pressure Therapy: Questioning of Patients With Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arterial Hypertension
Keywords: Hypertension
renal denervation
preference
shared decision making
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
Collaborators: name: Institute for Preventive Medicine
First posted: 2018-06-07
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * male and female
* \> 18 years

Brief summary: Written surveys of patients with high blood pressure are designed to determine how they would likely decide if, in addition to taking medication, they had another option to treat their hypertension.

The alternative treatment option is renal sympathetic denervation using catheter ablation. This new treatment method is not yet used in the standard care. Currently, studies are being conducted in specific centers to demonstrate the efficacy of this treatment.

Questionnaires are used to determine the preference of patients for one or the other option of hypertension treatment. So far, there are no findings.


Eligibility criteria: Inclusion Criteria:

* untreated Hypertension
* treated Hypertension with one or more medications

Exclusion Criteria:

* illiteracy

Primary outcomes:
measure: Preference of treatment
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nuremberg
country: Germany
facility: Institute for Preventive Medicine
Study officials:
References:
Clinical trial NCT00982150: Extension Study of Talampanel for Amyotrophic Lateral Sclerosis (ALS)
Official title: A Multinational, Multicenter, Open Label Phase to Assess Tolerability and Safety of Talampanel 50mg Tid in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Amyotrophic Lateral Sclerosis
Keywords: Talampanel
Open-Label Study
Amyotrophic Lateral Sclerosis
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2009-09-23
Enrollment: 446
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This will be an open label treatment extension phase in patients with ALS who have previously participated in the double blind, placebo-controlled ALS-TAL-201 study. This study will make talampanel treatment available to all subjects who completed the double blind placebo-controlled phase of ALS-TAL-201 study and where the investigator and patient consider it to be in the patient's interest to receive talampanel 50mg three times daily (tid). It will also enable the exploration of long-term safety and tolerability of talampanel 50mg tid.


Eligibility criteria: Inclusion Criteria:

* Patients must have completed 52 weeks of treatment of the double blind placebo-controlled phase of ALS-TAL-201.
* Women must be postmenopausal, surgically sterile, or using adequate birth control methods.
* Patients must be willing and able to give written informed consent prior to performing any open-label study procedures.

Exclusion Criteria:

* Patients with ECG signs of Brugada syndrome and/ or complete or incomplete Right Bundle Branch Block
* Patients using any of the following:

  * Chronic use of lithium carbonate
  * Chronic use of mecasermin (rhIGF-1)
  * Chronic use of minocycline
  * Chronic use of more than 600mg/day coenzyme Q10
  * Chronic use of any marketed drug, if its use was not clearly indicated for any underlying medical condition other than ALS (symptomatic drugs for ALS and supplements allowed)
* Patients participating in any other investigational drug study and use of any other investigational drug
* Patients taking drugs that may interact with Talampanel
* Females who are pregnant or nursing.
* Females of child-bearing potential who do not practice medically acceptable methods of contraception.
* Any condition of the patient which the investigator feels may interfere with participation in the study.

Primary outcomes:
measure: ALSFRS-R
timeFrame: every 4 weeks
Secondary outcomes:
measure: Vital Signs, ECG, Adverse Event Reports
timeFrame: every 26 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01366950: Work Place Health Promotion: a Change Project
Official title: Work Place Health Promotion as a Change Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Health Prevention
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2011-06-06
Enrollment: 406
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to determine if intelligent physical exercise training can increase the productivity of office workers in Denmark. Effects of intervention is measured after 1 and 2 years.

The project is driven as a change project.

The investigators measure productivity as:

* Individual health
* Sick leave
* Retention at the workplace


Eligibility criteria: Inclusion Criteria:

* Office workers

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: aerobic capacity
timeFrame: After 1 and 2 years
Secondary outcomes:
measure: sick leave
timeFrame: After 1 and 2 years
measure: Individual productivity
timeFrame: After 1 and 2 years
measure: Retention
timeFrame: After 1 and 2 years
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Nestlé
city: Esbjerg
country: Denmark
facility: Esbjerg Municipality
city: Odense and Copenhagen
country: Denmark
facility: National Board of Social Sciences
city: Sønderborg
country: Denmark
facility: TDC
city: Varde
country: Denmark
facility: Varde Kommune
Study officials:
affiliation: University of Southern Denmark
name: Gisela Sjoegaard, Professor
role: STUDY_DIRECTOR
References:
citation: Justesen JB, Sogaard K, Dalager T, Christensen JR, Sjogaard G. The Effect of Intelligent Physical Exercise Training on Sickness Presenteeism and Absenteeism Among Office Workers. J Occup Environ Med. 2017 Oct;59(10):942-948. doi: 10.1097/JOM.0000000000001101.
citation: Sjogaard G, Justesen JB, Murray M, Dalager T, Sogaard K. A conceptual model for worksite intelligent physical exercise training--IPET--intervention for decreasing life style health risk indicators among employees: a randomized controlled trial. BMC Public Health. 2014 Jun 26;14:652. doi: 10.1186/1471-2458-14-652.
Clinical trial NCT01785550: Neuromuscular Ultrasound in ALS
Official title: Ultrasonography in Amyotrophic Lateral Sclerosis as a Predictor of Disease Progression and Tool in Diagnosis: a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ALS
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-02-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients referred to the electromyography laboratory for ALS.

Brief summary: Amyotrophic Lateral Sclerosis (ALS) is a progressive fatal neurodegenerative disease affecting motor neurons. Early diagnosis is essential for the success of clinical trials and objective biomarkers are needed for monitoring disease progression. Nerve and muscle ultrasound may provide this information.

This study will collect pilot data to evaluate the value of muscle and nerve ultrasound to identify and monitor disease progression in ALS.


Eligibility criteria: Inclusion Criteria:

* Subjects referred to the electromyography laboratory for ALS.

Exclusion Criteria:

* Patients with known comorbid myopathy or neuropathy will be excluded from the study.
* Patients unable to provide their own consent will be excluded.

Primary outcomes:
measure: Abnormalities at onset: Ultrasound vs. Electromyography
timeFrame: 1 year
Secondary outcomes:
measure: Ultrasound Predicting Outcome at 1 year
timeFrame: 1.5 years
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
References: