louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06558006: Safety and Efficacy Predimenol for Headache
Official title: Safety and Efficacy of Predimenol for Headache: A Preliminary Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Headache
Keywords: Predimenol
Headache
Lead sponsor: Dexa Medica Group
Sponsor class: INDUSTRY
Collaborators: name: Fakultas Kedokteran Universitas Indonesia
First posted: 2024-08-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, double-blind, placebo-controlled and randomized study aimed to obtain a description of the efficacy and safety of Predimenol in alleviating headache.

Detailed description: Predimenol is a bioactive fraction extracted from Phaleria macrocarpa pericarpium (Mahkota Dewa).

There will be 20 subjects per group (a total of 60 subjects) planned to be enrolled in the study.

The investigational drug: tablet @200 mg of Predimenol. Dose administration: one singe dose (two tablets) of Predimenol or Placebo.

Eligibility criteria: Inclusion Criteria:

1. Healthy men or women aged 18 to 60 years with acute moderate tomoderate-severe headache.
2. Signing the informed consent.

Exclusion Criteria:

1. Body temperature of \>37.3˚C and/or refuse to follow health protocol for COVID-19.
2. Known hypersensitivity to herbal drugs.
3. Pregnant or lactating women.
4. Have received any analgesic or anti-inflammatory drugs within the past 12 hours.
5. Presence of vomiting or diarrhea within the past 24 hours or still ongoing at the start of study.
6. Severe illness, e.g. severe hypertension, or any known organic diseases that may cause headache.

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: Time 0, 10 min, 20 min, 30 min, 1 hour, 2 hour
measure: Adverse events
timeFrame: Time 0, 10 min, 20 min, 30 min, 1 hour, 2 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Imeri Fkui
state: DKI Jakarta
city: Depok
country: Indonesia
facility: Klinik Satelit Makara UI Depok
state: Jawa Barat
Study officials:
affiliation: Department Pharmacology & Therapeutics Faculty of Medicine Universitas Indonesia
name: Nalfriadi Nalfriadi, MD,SpPD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04063306: Quality of Life of Taiwan People Living With HIV
Official title: Investigation on Quality of Life and Related Factors of Taiwan People Living With HIV
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV-1-infection
Lead sponsor: Taiwan AIDS Nurse Society
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2019-08-21
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult HIV-1 infected patients

Brief summary: To survey QoL and relevant factors in PLWH


Eligibility criteria: Inclusion Criteria:

* adult patient living with HIV, aged \>= 18 years old

Exclusion Criteria:

* known cognitive dysfunction or attention deficient to complete the survey

Primary outcomes:
measure: QoL status of Patient Living with HIV (PLWH) by WHOQOL-HIV Brief questionaire
timeFrame: in 4 weeks
measure: Medical Outcome of Patient Living with HIV (PLWH) by MOS-HIV questionaire
timeFrame: in 4 weeks
measure: Stigma Scale of Patient Living with HIV (PLWH) by Berger's HIV Stigma Scale
timeFrame: an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT05809206: Gluteus Maximus Versus Gluteus Medius Strength On Back Muscles Performance In Patients With Sacroiliac Dysfunction
Official title: Gluteus Maximus Versus Gluteus Medius Strength On Back Muscles Performance In Patients With Sacroiliac Dysfunction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sacroiliac Joint Dysfunction
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be conducted to compare between the effect of glutes maximus and glutes medius muscles strength on back muscle performance in patients with Sacroiliac joint dysfunction.

Detailed description: The purposes of this study are:

1. To investigate the effect of Gluteus maximus strengthening exercises and Gluteus medius strengthening exercises on back pain in patient with Sacroiliac joint dysfunction
2. To investigate the effect of Gluteus maximus strengthening exercises and Gluteus medius strengthening exercises on back muscle performance in patients with Sacroiliac joint dysfunction
3. To investigate the effects of Gluteus maximus strengthening exercises and Gluteus medius strengthening exercises on function in patient with Sacroiliac joint Dysfunction

Eligibility criteria: Inclusion Criteria:

* Age from 25-40 years.
* Patients with chronic lumbopelvic pain (more than 12 weeks) and clinical test positive for SIJD.
* The pain distribution and tenderness on palpation under the posterior superior iliac spine (PSIS) are reliable signs that the SIJ is the source of pain.
* Complaint of unilateral pain rather than bilateral pain is also considered more likely to be coming from an SIJ.
* Patients willing and able to participate in an exercise program safely and without cognitive impairments that would limit their participation.

Exclusion Criteria:

* Neurological disorder, psychosomatic disorder
* Tumor.
* Infection condition.
* Recent surgeries.
* Pregnancy.
* Back pain referred from organic cause.
* Osteoporosis and bone disease (induced or idiopathic).

Primary outcomes:
measure: Assessing the change in the peak torque of back muscles
timeFrame: at baseline and after 5 weeks of intervention
measure: Assessing the change in pain threshold
timeFrame: at baseline and after 5 weeks of intervention
measure: Assessing the change in Functional ability level
timeFrame: at baseline and after 5 weeks of intervention
measure: Assessing the change in pain intensity
timeFrame: at baseline and after 5 weeks of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Dokki
country: Egypt
facility: Outpatient clinic faculty of physica therapy cairo university
Study officials:
affiliation: Cairo University
name: Reham Abd El-Moneim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01701206: HOPE (Harnessing Online Peer Education): Using Online Social Networks for HIV Prevention and Testing
Official title: Using Online Social Networks for HIV Prevention and Testing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
social networking
at-risk populations
sexual risk behaviors
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2012-10-05
Enrollment: 558
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study seeks to determine whether social networking technologies can be used to increase HIV prevention and testing.The HOPE (Harnessing Online Peer Education) model seeks to apply a diffusion of innovations style intervention to social media to increase HIV testing.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Has had sex with a man in the past 12 months
* Lives in Lima or Callao, Peu
* Has a Facebook account or willing to create one

Exclusion Criteria:

* Does not satisfy inclusion criteria

Primary outcomes:
measure: HIV self-testing-Number of participants who request an HIV self-testing kit
timeFrame: Measured during the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Lima
country: Peru
facility: Epicentro Commun
Study officials:
References:
citation: Young SD, Cumberland WG, Nianogo R, Menacho LA, Galea JT, Coates T. The HOPE social media intervention for global HIV prevention in Peru: a cluster randomised controlled trial. Lancet HIV. 2015 Jan;2(1):e27-32. doi: 10.1016/S2352-3018(14)00006-X.
citation: Young SD, Cumberland WG, Lee SJ, Jaganath D, Szekeres G, Coates T. Social networking technologies as an emerging tool for HIV prevention: a cluster randomized trial. Ann Intern Med. 2013 Sep 3;159(5):318-24. doi: 10.7326/0003-4819-159-5-201309030-00005.
Clinical trial NCT04496206: Musculoskeletal Problems During Pregnancy
Official title: Musculoskeletal Problems During Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Most Common Musculoskeletal Problems in Pregnancy
Keywords: carpal tunnel syndrome
low back pain
pelvic girdle pain
Lead sponsor: Eskisehir City Hospital
Sponsor class: OTHER
First posted: 2020-08-03
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: One hundred and twenty pregnant women

Brief summary: Aim: This study was conducted to identify the most common musculoskeletal problems according to trimester, experienced by pregnant women.

Material and Methods: A total of 120 pregnant women who admitted to physical medicine and rehabilitation clinic, evaluated retrospectively in this study. Application complaints, the diagnosis and the trimester of the pregnant women and also age, weight, height, number of pregnancy, working status, presence of secondary disease were recorded.


Eligibility criteria: Inclusion Criteria:

Pregnant patients who have age, weight, size, employment status, duration of pregnancy, nulli/multi-parity, presence of other disorders, application complaints, the diagnosis information were included to the study

Exclusion Criteria:

Non-pregnant patients and pregnant patients with missing data were excluded from the study

Primary outcomes:
measure: Application complaints
timeFrame: 1 day
measure: the diagnosis
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Eskişehir
country: Turkey
facility: Eskişehir City Hospital
Study officials:
affiliation: Eskisehir City Hospital
name: Fulya Bakılan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02985606: How Does Altering the Timing of Pre-exercise Low-dose Caffeine Ingestion Affect Endurance Exercise Performance
Official title: How Does Altering the Timing of Pre-exercise Low-dose Caffeine Ingestion Affect Endurance Exercise Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Exeter
Sponsor class: OTHER
First posted: 2016-12-07
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Investigate how manipulating the time between caffeine ingestion and exercise may alter exercise performance and cognition


Eligibility criteria: Inclusion Criteria:

* vo2max \> 55 ml/kg/min
* females on contraceptive pill

Exclusion Criteria:

* recent skeletal muscle injury
* cardiovascular injury
* metabolic disease

Primary outcomes:
measure: Work done in kilojoules (kJ) during a 15 minute time trial on a cycle ergometer
timeFrame: 15 minutes
Secondary outcomes:
measure: Whole body fuel substrate utilisation measured using indirect calorimetry
timeFrame: 10 minutes
measure: Change in plasma caffeine concentration and metabolites
timeFrame: 2 hours 45 minutes
measure: Change in cognitive function measured using stroop test
timeFrame: 2 hours 45 minutes
measure: Collection of saliva for genotyping of CYP1A2
timeFrame: 30 mintes
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: Sport and Health Sciences
state: Devon
Study officials:
References:
citation: Davenport AD, Jameson TSO, Kilroe SP, Monteyne AJ, Pavis GF, Wall BT, Dirks ML, Alamdari N, Mikus CR, Stephens FB. A Randomised, Placebo-Controlled, Crossover Study Investigating the Optimal Timing of a Caffeine-Containing Supplement for Exercise Performance. Sports Med Open. 2020 Mar 30;6(1):17. doi: 10.1186/s40798-020-00246-x.
Clinical trial NCT06070506: Heart Failure With Improved Ejection Fraction and Deep Learning
Official title: Deep Learning-Based Prediction Model of Heart Failure With Improved Ejection Fraction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Diagnosis
Keywords: Heart failure
Left ventricular ejection fraction
Heart failure with improved ejection fraction
Deep learning
Lead sponsor: First Affiliated Hospital of Harbin Medical University
Sponsor class: OTHER
First posted: 2023-10-06
Enrollment: 422
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The participants in the study are HF patients hospitalized in the Department of Cardiology of the First Affiliated Hospital of Harbin Medical University who had no less than two echocardiograms at baseline and during the follow-up period, between January 2014 to December 2022.

Brief summary: The aim of this study was to design a deep learning-based trained model to assist in HFimpEF diagnosis.


Eligibility criteria: Inclusion Criteria:

1. Age \>18 years.
2. The diagnostic criteria of HF follows the 2018 Chinese Guidelines for the Diagnosis and Treatment of Heart Failure, having symptoms of dyspnea, fatigue or decreased activity tolerance, having signs of fluid retention (such as pulmonary congestion and peripheral edema), having echocardiogram abnormalities in cardiac structure and/or function, showing elevated natriuretic peptide levels (BNP\>35 ng/L or/and N-terminal pro-BNP \>125 ng/L).
3. Have reviewing echocardiography after discharge.

Exclusion Criteria:

1. Patients with hypertrophic, restrictive, or invasive cardiomyopathy and congenital or rheumatic heart disease.
2. Patients with heart transplantation during follow-up.

Primary outcomes:
measure: change of left ventricular ejection fraction
timeFrame: 3 months
Secondary outcomes:
measure: change of clinical predictor of EF improvement
timeFrame: 3 months
measure: the independent clinical predictor of HFimpEF
timeFrame: 3 months
Other outcomes:
Locations:
city: Harbin
country: China
facility: Yihui Kong
state: Heilongjiang
Study officials:
References:
Clinical trial NCT04856449: DBT Skills Plus EMDR for BPD and Trauma
Official title: A Pilot Randomized-controlled Study of Dialectical Behavioral Skills Training Plus EMDR for Borderline Personality Disorder and Trauma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Borderline Personality Disorder
Trauma
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
Collaborators: name: EMDR Europe
First posted: 2021-04-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Borderline Personality Disorder (BPD) is a severe disorder that frequently co-occurs with post-traumatic stress disorder (PTSD). The comorbidity of BPD and PTSD is more disabling, predicting lower rates of BPD remission. Dialectical behavioral skills training (DBT-ST), is a group-delivered training that covers four types of skills: emotion regulation, mindfulness, interpersonal effectiveness and distress tolerance. As a stand-alone treatment, research suggest that DBT-ST is an efficacious treatment for BPD. In parallel, EMDR has emerged in last years as an efficacious approach to adult trauma. However, so far, the efficacy of EMDR to treat trauma in populations with BPD diagnosis has not been tested. The present pilot randomized-controlled clinical trial aims to test whether a combination of DBT-ST plus EMDR could be efficacious to treat trauma in individuals with BPD. 40 participants will be recruited from the BPD Unit at the Hospital de la Santa Creu I Sant Pau (Barcelona, Spain) and will be randomized (1:1) to DBT-ST + EMDR or DBT-ST alone. The primary outcome will be the reduction of PTSD symptoms. In addition, symptom-related variables will be collected before and after the interventions. This will be the first study to test the combination of DBT-ST and EMDR.


Eligibility criteria: Inclusion Criteria:

* men and women between 18 and 60 years old
* having had adverse childhood experiences and/or current PTSD symptoms
* signed informed consent

Exclusion Criteria:

* lifetime diagnosis of schizophrenia, drug-induced psychosis, organic brain syndrome, bipolar disorder, or mental retardation.
* participation in any psychotherapy during the study or having received DBT or EMDR in the past

Primary outcomes:
measure: Borderline Symptom List 23 (BSL-23)
timeFrame: 1 week
Secondary outcomes:
measure: Impact of Events Scale Revised
timeFrame: 1 week
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 2 weeks
measure: DISSOCIATIVE EXPERIENCES SCALE (DES)
timeFrame: 1 month
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
state: Catalonia
Study officials:
References:
Clinical trial NCT00418249: Topical AS101 for Treatment of FAGA (Female Androgenetic Alopecia) in Menopause Women
Official title: Phase 2 Study of Topical AS101 for the Treatment of FAGA (Female Androgenetic Alopecia) in Menopause Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Alopecia
Keywords: Androgenetic Alopecia
Telogen effluvium
Chronic telogen effluvium
Menopause
Female Androgenetic Alopecia (FAGA)
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2007-01-04
Enrollment: 40
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to assess the safety and efficacy of topical AS101 as treatment for Female Androgenetic Alopecia (FAGA) in menopause women.


Eligibility criteria: Inclusion Criteria:

* Women in menopause, over 50 years of age.
* Clinically diagnosed for AGA, according to Ludwig scale I-II.

Exclusion Criteria:

* Women treated with chronic medications.
* Use of Minoxidil within 3 months prior to entering study.
* Women who have underwent hair transplantation.
* Use of drugs with androgenic or anti-androgenic effects.
* Any other type of hair loss.

Primary outcomes:
measure: hair density
Secondary outcomes:
measure: Hair diameter, anagen/telogen ratio and hair growth rate,Global photographic assessment according to Female-Ludwig scale,
measure: Self-administered satisfaction questionnaire
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
Study officials:
affiliation: Rabin Medical Center
name: Danny Ben-Amitai, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06164249: Quantification of Internal Training Load
Official title: Quantification of Internal Training Load: Toward the Prediction of the Distribution of Hypertrophy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypertrophy
Resistance Training
Muscle
Keywords: Muscle activation
Muscle volume
Muscle stress
Muscle mass
Lead sponsor: Université de Nantes
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three independent groups :

* Control (no strengthening)
* Nordic (strengthening in Nordic Hamstring exercise)
* Deadlift (strengthening in Deadlift exercise)
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to determine whether the distribution of internal load predicts the distribution of muscle hypertrophy among hamstring heads after a 10-week resistance exercise program. The hypothesis is that the distribution of internal muscle load among the hamstring is related to the distribution of muscle hypertrophy.

Detailed description: It is well accepted that muscle stress (mechanical and/or metabolic) is the major way to induce muscle hypertrophy. While this link between muscle stress and hypertrophy is pivotal is sport training, prevention and rehabilitation, it remains poorly understood. To date, the only indirect evidence of relationship of muscle stress and muscle hypertrophy is the similar patterns (from independent studies) between muscle damage and hypertrophy within quadriceps (i.e., rectus femoris (RF) \> vastus (VL) = vastus medialis VM), hamstring, and triceps surae. However, muscle damage is an indirect proof of muscle mechanical stress. With the quantification of internal muscle load, it is interesting to determine whether the muscle that receives the larger stress exhibits the larger hypertrophy.

Eligibility criteria: Inclusion Criteria:

* No history of lower limb injury
* No chronic pathology associated with a long term care

Exclusion Criteria:

* Individual enrolled in a research study

Primary outcomes:
measure: Muscle volume
timeFrame: 10 weeks
measure: Internal training load
timeFrame: 10 weeks
Secondary outcomes:
measure: Maximal strength Nordic
timeFrame: 10 weeks
measure: Maximal strength Deadlift
timeFrame: 10 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01908036: Use of a Monitor in ME/CFS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Fatigue Syndrome
Keywords: Chronic fatigue syndrome
CFS
myalgic encephalomyelitis
M.E.
activity monitor
Lead sponsor: New York CFS Association
Sponsor class: OTHER
First posted: 2013-07-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50 CFS patients

Brief summary: The use of an activity monitor to determine increase or decrease of activity in patients suffering from chronic fatigue syndrome.

Detailed description: A cohort of 50 patients suffering from chronic fatigue syndrome will be given an informed release form. Have a signed the informed release they will be given a Fitbit activity monitor. These monitors will be evaluated on a weekly interval by computer interface. The activity will be calculated to determine the online of activity and whether there is increase or decrease in activity during the time of the study. The study is an observational rather than an interventional study. There is no invasion or intervention in the patient's normal activities

Eligibility criteria: Inclusion Criteria:

Fukuda and Canadian consensus criteria for the diagnosis of chronic fatigue syndrome

Exclusion Criteria:

Acute disease and exclusion conditions in Fukuda criteria

Primary outcomes:
measure: observation of activity level in CFS patients
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Me/Cfs Center,860 Fifth Avenue
state: New York
Study officials:
References: