louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04701463: A Specialized Amino Acid Mixture on Body Composition and Skin State in Overweight and Obese Class I Postmenopausal Women
Official title: Effect of a Specialized Amino Acid Mixture on Body Composition and Skin State in Overweight and Obese Class I Sedentary Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amino Acid
Body Weight Changes
Skin Manifestations
Obesity
Postmenopausal Disorder
Lead sponsor: Azienda di Servizi alla Persona di Pavia
Sponsor class: OTHER
First posted: 2021-01-08
Enrollment: 20
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The use of dietary amino acids has been explored for therapeutic and safety intervention of obesity and obesity-induced dysfunction. In particular, 3 molecules have been shown to be effective both in the animal model and in humans, in promoting the loss of fat mass, specifically visceral adipose tissue, and in maintaining free fat mass: arginine, glutamine and leucine (and its metabolite beta hydroxy methyl butyrate, HMB). The aim of this study was to evaluate the efficacy in terms of fat mass, in particular Visceral Adipose Tissue reduction, as primary end point, in obese patients following the administration of specific food for special medical purposes (FSMP) for muscle recovery, consisting of arginine, glutamine and HMB. The secondary end point is the evaluation of skin state, by a validate self-reported questionnaire survey to assess skin, after 4- weeks intake of this FSMP.


Eligibility criteria: Inclusion Criteria:

* Postmenopause
* Obesity (I class) or overweight

Exclusion Criteria:

* Taking any medication
* Having liver, renal and thyroid disease
* Smoking
* Drinking more than two standard alcoholic beverages/day (20 g of alcohol/day)

Primary outcomes:
measure: Changes on Visceral Adipose Tissue
timeFrame: Baseline / 30 days
Secondary outcomes:
measure: Changes on Body Composition
timeFrame: Baseline / 30 days
measure: Changes on Metabolic parameters
timeFrame: Baseline / 30 days
measure: Changes on Metabolic parameters
timeFrame: Baseline / 30 days
measure: Changes on Metabolic parameters
timeFrame: Baseline / 30 days
measure: Changes on anthropometric measurements
timeFrame: Baseline / 30 days
measure: Changes on anthropometric measurements
timeFrame: Baseline / 30 days
measure: Changes on skin condition
timeFrame: Baseline / 30 days
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Azienda di Servizi alla Persona
Study officials:
References:
Clinical trial NCT06262763: High-intensity Laser Therapy for Sacroiliac Joint Pain
Official title: Effect of High Intensity Laser on Sacroiliac Joint Pain In Adult Women
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sacroiliac Joint Pain
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2024-02-16
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Effect of high intensity laser on sacroiliac joint pain

Detailed description: Effect of high laser in reduction of pain and improve functional disability in adult women

Eligibility criteria: Inclusion Criteria:

* The presence of Pain over the sacroiliac joint with no surgical history.
* Unmarried.
* Tender SIJ on palpation.
* Workers with an average age of 18-30 years.
* Body mass index did not exceed 30 kg/m2.

Exclusion Criteria:

* If they have Infections. .Fracture in and around the SIJ Complex.
* Arthritis of joint.
* Pregnancy. .Smoking girls. .Patient not willing to participate in the study. .Any history of surgery. Lumbar spine disc herniation or back injury. Tumor around the joint.

Primary outcomes:
measure: Pain intensity
timeFrame: At the beginning and at after 12 session (1 month)
Secondary outcomes:
measure: Pressure pain threshold
timeFrame: At the beginning and at after 12 session (1 month)
Other outcomes:
measure: Functional disability
timeFrame: At the beginning and at after 12 session (1 month)
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Kafr Al-Sheikh University
Study officials:
References:
Clinical trial NCT03979235: Developing Effectiveness Evaluation and Therapeutic Programs of Rehabilitation
Official title: Developing Clinic-oriented Quantitative Effectiveness Evaluation and Individualized Therapeutic Programs of Rehabilitation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy Volunteers
Motor Deficits
Dysphagia
Lead sponsor: National Research Center for Rehabilitation Technical Aids
Sponsor class: OTHER
First posted: 2019-06-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Recruiting with advertising

Brief summary: Using robotics, sensors, and sEMG to develop clinic-oriented quantitative effectiveness evaluation and individualized programs of rehabilitation

Detailed description: Using robotics, sensors, sEMG or other methods to develop clinic-oriented quantitative effectiveness evaluation and individualized programs of rehabilitation

Eligibility criteria: Inclusion Criteria (for healthy people):

* no history of psychological/psychotic problems, no history of important diseases.

Exclusion Criteria (for healthy people):

* history of psychological/psychotic problems

Inclusion Criteria (for patients with motor deficits or dysphagia):

* patients with motor function impairment such as post stroke hemiplegia.

Exclusion Criteria (for patients with motor deficits or dysphagia):

* cognitively or physically unable to cooperate with the examiner to finish the test

Primary outcomes:
measure: Motor function assessment
timeFrame: Change from Baseline scores at 1 month
Secondary outcomes:
measure: surface EMG
timeFrame: Change from Baseline status at 1 month
measure: Kinematics test
timeFrame: Change from Baseline status at 1 month
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Research Center for Rehabilitation Technical Aids
Study officials:
affiliation: National Research Center for Rehabilitation Technical Aids
name: PX Wei, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05231135: A Registry Study on HIV-related Lymphoma
Official title: Characteristics, Treatment and Outcomes of HIV-infected Patients With Malignant Lymphoma: A Registry Study of the European Hematology Association (EHA) Lymphoma Group
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: AIDS Related Lymphoma
HIV Related Lymphoma
Keywords: Malignant lymphoma
HIV-related lymphoma
HIV-associated Hodgkin lymphoma
Lead sponsor: Rotkreuzklinikum München gGmbH
Sponsor class: OTHER
First posted: 2022-02-09
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Unselected cohort of adults with HIV-lymphoma

Brief summary: Retrospective und prospective registry on HIV-associated lymphoma. Data on characteristics, type and toxicity of treatment and outcome of patients with HIV-lymphoma will be collected.

Detailed description: To study characteristics, treatment approaches and outcome of HIV-infected patients with malignant lymphoma in the combination antiretroviral therapy (cART) era. HIV-infected persons diagnosed with non-Hodgkin lymphoma or Hodgkin lymphoma will be included. The choice of treatment is not specified by the registry study. However, the type of antineoplastic treatment should follow national or international recommendations and guidelines. Data will be pseudonymized by the data manager of the treating institution. Central data management is located at Red Cross Hospital Munich, Germany.

Eligibility criteria: Inclusion Criteria:

* Histology or cytology proven non-Hodgkin lymphoma or Hodgkin lymphoma
* HIV-infection at time of lymphoma diagnosis
* Lymphoma diagnosis since 01.01.2010
* Adult patients ≥ 18 years
* Written informed consent

Exclusion Criteria:

* HIV-diagnosis \> 3 months after the diagnosis of malignant lymphoma
* Non-Compliance or lack of opportunity for follow-up (for the prospective part of the study)

Primary outcomes:
measure: 2-year overall survival (OS)
timeFrame: 2 years
measure: 2-year progression-free survival (PFS)
timeFrame: 2 years
Secondary outcomes:
measure: Incidence of relapse (IR)
timeFrame: 5 years
measure: Non-relapse mortality (NRM)
timeFrame: 5 years
measure: 5-year overall survival (OS)
timeFrame: 5 years
measure: 5-year progression-free survival (PFS)
timeFrame: 5 years
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Red Cross Hospital Munich
state: Select One Option
city: Cologne
country: Germany
facility: University Hospital Cologne
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Centers
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
Study officials:
affiliation: Rotkreuzklinikum München
name: Marcus Hentrich, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06658535: A Dose Escalation Study of NanO2 in Patients With Mild Respiratory Distress
Official title: Novel Oxygen Therapeutic NanO2 for Mild Respiratory Distress in Phase 1b
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Mild Respiratory Distress
Keywords: respiratory distress
Lead sponsor: NuvOx LLC
Sponsor class: INDUSTRY
First posted: 2024-10-26
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Up to six subjects will be enrolled at each dose level
Primary purpose: TREATMENT

Brief summary: EXTEND is a dose escalation study of NanO2™ in patients with mild respiratory distress who are at risk for mechanical ventilation. The study will establish dosing guidelines for a Phase 2 study.


Eligibility criteria: Inclusion Criteria:

* Requiring supplemental oxygen but ≤ 6L oxygen by nasal cannula to maintain an oxygen saturation \>92% or PaO2 \>60mmHg
* Admitted to a hospital with symptoms of mild RD
* Signed informed consent obtained from the subject or subject's legally authorized representative
* Agrees to not participate in another clinical trial for the treatment of mild RD through Day 28

Exclusion Criteria:

* Presence of extracorporeal membrane oxygenation
* Unstable hypertension
* History of significantly impaired renal function defined as an eGFR ≤ 30mL/min/1.73m2 (MDRD equation or similar) or impaired hepatic function defined as the presence of decompensated cirrhosis (acute deterioration in liver function characterized by jaundice, ascites, hepatic encephalopathy, hepatorenal syndrome, or variceal hemorrhage)
* Presence of pulmonary embolism at baseline
* Evidence of right ventricular heart failure
* Unstable hemodynamically as defined by receiving 0.5μg/kg/min or greater norepinephrine
* Inability to comply with the study procedures
* Currently pregnant or breastfeeding
* Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 48 hours
* History or evidence of any other clinically significant condition that, in the opinion of the investigator, might pose a safety risk to subjects or interfere with study procedures, evaluation, or completion

Primary outcomes:
measure: Maximum Tolerated Dose
timeFrame: 28 Days
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: 28 days
Other outcomes:
measure: Change in Respiratory Rate Oxygenation (ROX) Index score
timeFrame: 24 hours
measure: World Health Organization (WHO) 8-point scale for clinical assessments
timeFrame: 28 days
measure: NanO2 Oxygenation
timeFrame: 2 days
measure: Determine the effects of NanO2 on PaO2 measurements
timeFrame: 2 days
Locations:
city: Edmonton
country: Canada
facility: Grey Nun Community Hospital
state: Alberta
city: Montréal
country: Canada
facility: Hôpital Maisonneuve Rosemont
state: Quebec
Study officials:
References:
Clinical trial NCT00219635: Assessment Of Efficacy and Safety UK-390,957 In Men With Premature Ejaculation
Official title: A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled, Flexible Dose Study To Assess The Efficacy and Safety Of Oral UK-390,957 In Men With Premature Ejaculation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Ejaculation
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 138
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Assessment of efficacy and safety UK-390,957


Eligibility criteria: Inclusion Criteria:

* Premature ejaculation as defined by DSM-IV

Exclusion Criteria:

* History of erectile dysfunction

Primary outcomes:
measure: Assessment of efficacy and safety
Secondary outcomes:
measure: Assessment of quality of sexual life
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: San Bernardino
country: United States
facility: Pfizer Investigational Site
state: California
city: Metairie
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Watertown
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Kansas City
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Washington
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Williamsville
country: United States
facility: Pfizer Investigational Site
state: New York
city: Beachwood
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Knoxville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Milwaukee
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: St Leonards
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Malvern
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Victoria
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Barrie
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: London
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Nr Lichfield
country: United Kingdom
facility: Pfizer Investigational Site
state: Staffordshire
city: Devon
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06787235: Nutritional Intervention to Reduce Alcohol Consumption
Official title: Nutritional Intervention to Reduce Alcohol Consumption
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder
Lead sponsor: University of Bern
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To test whether the implementation of a modified ketogenic diet (KD) is efficient in reducing outcome measures in relation to alcohol consumption in patients with alcohol use disorder (AUD).

Detailed description: This pilot study aims at testing randomization and feasibility of implementing a modified KD in patients with AUD undergoing standard alcohol withdrawal treatment. For this purpose, a a standardized nutritional intervention consisting of interprofessional consultations by clinical dieticians and medical professionals will be implemented. Patients in the control group will be randomized in an AUD as usual treatment with an additional optional nutritional consultation. After dismission of inpatient care, the participants will be followed up for adherence to the modified KD in the outpatient clinic for 5 weeks.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18
* AUD diagnosis according to Diagnostic and Statistical Manual (DSM)-5
* BMI \> 22 (because of potential modified KD-side effect of weight loss)
* Able to give informed consent as documented by signature
* Last alcohol drink intake within 72 hours before treatment initiation

Exclusion Criteria:

* Pregnant or lactating women,
* Inability or contraindications to undergo the investigated intervention (BMI\<18)
* Clinically significant concomitant diseases impairing reasonable decision making (e.g. psychosis, dementia)
* Inability to follow the procedures of the study, e.g. due to language problems, Previous enrolment in a clinical trial
* Patients undergoing opioid maintenance treatment
* Patients taking medications for drinking relapse prevention
* Patients with a blood hemoglobin A1C (HbA1C) \> 7%

Primary outcomes:
measure: Modified ketogenic diet (KD)
timeFrame: 8 weeks
Secondary outcomes:
measure: Drinking outcome
timeFrame: 8 weeks
measure: Nutritional outcome
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University of Bern
Study officials:
affiliation: University of Bern
name: Philippe Pfeifer
role: STUDY_CHAIR
References:
Clinical trial NCT03342586: Using a Novel Functional MRI Technique to Evaluate for Neurotoxicity
Official title: Changes in Resting State Functional Connectivity in Patients With Central Nervous System Lymphoma Receiving High Dose Chemotherapy and Autologous Stem Cell Transplant
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Central Nervous System Lymphoma
Keywords: resting state functional Magnetic Resonance Imaging
rsfMRI
17-403
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Rutgers University
First posted: 2017-11-17
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential research subjects will be identified by a member of the patient's treatment team, listed protocol investigators, or Neuroradiology research team at Memorial Sloan Kettering Cancer Center (MSKCC).

Brief summary: The purpose of this study is to test resting state functional Magnetic Resonance Imaging (rsfMRI) scans to see if rsfMRI scans are better than the standard task based fMRI scans at diagnosing or monitoring central nervous system lymphoma.


Eligibility criteria: Inclusion Criteria:

* Immunocompetent patients with newly diagnosed or recurrent non-Hodgkins lymphoma involving the brain (primary or secondary), as demonstrated by MRI and histologic confirmation either by positive CSF cytology for lymphoma or a monoclonal lymphocyte population defined by cell surface markers, vitreous or uvea biopsy or brain biopsy
* Age 18-80 years
* Treatment plan for HDC-ASCT
* Fluent in English
* Patients who in the judgment of the investigators and/or consenting professional, are able to understand the purpose of the study and provide informed consent will be included.

Exclusion Criteria:

* Claustrophobia
* Any contraindication to the use of contrast and/or general guidelines for MR imaging as per standard Department of Radiology imaging guidelines
* Unable to cooperate for MRI

Primary outcomes:
measure: Change in resting state brain networks over time in participants with central nervous system lymphoma before and after treatment with high-dose chemotherapy with autologous stem cell transplantation through resting state fMRI results
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Behroze Vachha, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04558086: The Effects of Using an Interactive Game With Virtual Reality for Children During Intravenous Placement
Official title: The Effects of Using an Interactive Game With Virtual Reality to Reduce the Pain and Fear for Children During an Intravenous Placement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pian
Fear
Keywords: Therapeutic play,virtual reality, intravenous placement, school-age, pain, fear
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2020-09-22
Enrollment: 134
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To develop the intervention strategies of hospitalized school-age children with IV placement, using interactive virtual reality(VR)as a guiding play and emotional catharsis play, to further examine the effectiveness of reducing IV pain and fear.


Eligibility criteria: Inclusion Criteria:

* Children ages 6-12.
* Children who where clearly conscious.
* Children who agreed and were required to receive intravenous injections after physicians' diagnoses.
* Children and their primary caregivers who could communicate in Mandarin or Taiwanese
* Children and their primary caregivers who could read Chinese that agreed to participate in this study and sign written consent forms

Exclusion Criteria:

* Children with developmental delay, epilepsy, or heart diseases
* Children undergoing chemotherapy; children who were visually or hearing impaired
* Children who were nearsighted with more than 8.0 diopters or farsighted with 5.0 diopters.
* Children who had sustained head trauma in the past month
* Children who were confirmed to be obese according to the recommended body mass index values for children and adolescents
* Children who required blood transfusions and blood preparation to be performed according to physician diagnoses
* Children who received two or more intravenous injections and had their blood drawn only one time

Primary outcomes:
measure: The degrees of pain experienced by the children.
timeFrame: The posttests 8 min after the tourniquets were worn.
measure: The degrees of fear experienced by the children.
timeFrame: The posttests 8 min after the tourniquets were worn.
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei county
country: Taiwan
facility: National Yang-Ming University
Study officials:
References: