louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01244659: A Randomized Study Assess the Safety and Efficacy of Tacrolimus vs Prograf® in Renal Transplantation Treatment
Official title: An Open Randomized Non-inferiority Study to Compare Safety and Efficacy of Immunosuppressive Regiments Using Tacrolimus From EMS and Prograf® in Post Renal Transplanted Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Renal Transplant
Keywords: Tacrolimus
Immunosuppressive Agents
Kidney transplantation
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2010-11-19
Enrollment: 0
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: Comparison of safety and efficacy of immunosuppressive regiments using tacrolimus from EMS and Prograf® in post renal transplanted patients.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 year old
* Patient is receiving kidney from live or death donor
* Kidney donor younger than 65 years old
* PRA ≤ 30%
* Negative pregnancy test for women
* Patient agreement to practice birth control
* Patient has been fully informed and has given written informed consent

Exclusion Criteria:

* HLA identical
* Patient multi-organ transplant recipient
* Any pathology or past medical condition that can interfere with this protocol
* Allergy or intolerance of any study medication

Primary outcomes:
measure: Efficacy
timeFrame: day 1 to day 180
Secondary outcomes:
measure: Safety
timeFrame: day 1 to day 180
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Santa Casa de Misericórdia de Porto Alegre
state: RS
Study officials:
affiliation: EMS
name: Felipe Pinho, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03468959: Maternal Polyunsaturated Fatty Acids in Association With Child Autism Spectrum Disorder in the MARBLES Study
Official title: Maternal Polyunsaturated Fatty Acids in Association With Child Autism Spectrum Disorder in the MARBLES Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autism Spectrum Disorder
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2018-03-19
Enrollment: 252
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Families were recruited from lists of children receiving autism services obtained via the California Department of Developmental Services (DDS), from other studies at the Medical Investigation of Neurodevelopmental Disorders (MIND) Institute, or by self-referrals.

Brief summary: This study is to examine the association between maternal omega3 and other polyunsaturated fatty acids (PUFAs) during pregnancy and autism spectrum disorder (ASD) as well as other non-typical development (Non-TD) in the prospective Markers of Autism Risk in Babies-Learning Early Signs (MARBLES) cohort.


Eligibility criteria: Inclusion Criteria:

* Mother or father had a biological child with ASD
* Mother is at least 18 years old
* Mother is pregnant or planning a pregnancy, and biologically able to become pregnant
* Mother is living within 2 hours of the MIND Institute
* Mother is sufficiently fluent in English

Exclusion Criteria:

* Mothers with diseases which will influence on their study participation

Primary outcomes:
measure: autism spectrum disorder group (ASD)
timeFrame: 36 months
Secondary outcomes:
measure: A group of typically development (TD) people
timeFrame: 36 months
Other outcomes:
measure: A group of non-typical development (Non-TD) people
timeFrame: 36 months
Locations:
Study officials:
References:
Clinical trial NCT06715059: Tele-rehabilitation in Women With Diastasis Recti Abdominis
Official title: Effects of Tele-rehabilitation on Inter-Recti Distance, Postural Balance, Abdominal Endurance and Pelvic Floor Functions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diastasis Recti
Diastasis Recti and Weakness of the Linea Alba
Keywords: inter-recti distance
postural control
pelvic floor dysfunction
body-self relation
abdominal endurance
Lead sponsor: Atlas University
Sponsor class: OTHER
First posted: 2024-12-04
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this randomized controlled study is to determine the effect of motor-control based telerehabilitation exercise program on inter-recti distance, abdominal endurance, pelvic floor dysfunction, and body-image perception in women with diastasis recti abdominis.

Researchers will compare the effects of motor-control-based telerehabilitation exercise program and conventional exercise programs in women with DRA.

Detailed description: Diastasis of recti abdominis (DRA) is defined as a separation of the two rectus abdominis muscles along the linea alba. Increased volume in the abdominal cavity, hormonal changes during pregnancy, neurodevelopmental differences, or abdominal wall laxity may caused. It is very common during pregnancy and may continue in the postnatal period. The loss of abdominal wall stability and weakened pelvic floor muscles may occur with DRA. The abdominal wall is one of the key point for body posture, trunk and pelvic stability. The core stability exercises, pelvic floor training and trunk muscle trainings are some of the exercise regimes options for management of DRA. However, in our best knowledge, there is no study in the literature that evaluates the effect of motor-control based telerehabilitation exercise program in women with DRA.

Eligibility criteria: Inclusion Criteria:

* Post- partum women (min 1 - max 5 years)

Exclusion Criteria:

* Having a neurological, orthopedical or any other condition which affect postural stability.

Primary outcomes:
measure: Inter-recti distance
timeFrame: baseline
measure: Inter-recti distance
timeFrame: after 8 weeks
Secondary outcomes:
measure: Abdominal muscle endurance test
timeFrame: baseline
measure: Abdominal muscle endurance test
timeFrame: After 8 weeks
measure: Pelvic floor dysfunction
timeFrame: baseline
measure: Pelvic floor dysfunction
timeFrame: After 8 weeks
measure: Body-self relation
timeFrame: baseline
measure: Body-self relation
timeFrame: After 8 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Atlas University
state: KAgıthane
city: İstanbul
country: Turkey
facility: Atlas University
state: Kağıthane
Study officials:
affiliation: İSTANBUL ATLAS ÜNİVERSİTESİ
name: Hilal DENİZOĞLU KÜLLİ
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03931759: The Effect of Intra-abdominal Pressure
Official title: The Effect of Intra-abdominal Pressure, Applied to the Patients Diagnosed With Diabetes Mellitus, Who Undergo Laparoscopic Surgery, on Hemodynamics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus
ASA Triad
Cardiac Autonomic Neuropathy
Keywords: diabetes mellitus
cardiac autonomic neuropathy
laparoscopic surgery
Lead sponsor: Erzincan University
Sponsor class: OTHER
First posted: 2019-04-30
Enrollment: 130
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: prospective randomize clinical trial
Primary purpose: SCREENING

Brief summary: The Effect of Intra-abdominal Pressure

Detailed description: The Effect of Intra-abdominal Pressure, Applied to the Patients Diagnosed with Diabetes Mellitus, Who Undergo Laparoscopic Surgery, on Hemodynamics

Eligibility criteria: Inclusion Criteria:

* diabetes mellitus
* laparoscopic surgery

Exclusion Criteria:

* hypertension
* hearth failure
* renal failure
* hepatic failure
* difficult intubation
* shock

Primary outcomes:
measure: The measurement of heart rate variability in laparoscopic surgeries
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06737159: Utility of Severity Scales in Clinical Practice in Children Hospitalized Due to Bronchiolitis.
Official title: Utility of Severity Scales in Clinical Practice in Children Hospitalized Due to Bronchiolitis: Prospective Multicentre Cohort Study.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Bronchiolitis
Keywords: bronchiolitis
bronchiolitis severity scoring
validation
utility
Lead sponsor: Szpital im. Św. Jadwigi Śląskiej
Sponsor class: OTHER
First posted: 2024-12-17
Enrollment: 150
Sex: ALL
Minimum age (years): 5
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients with diagnosis of bronchiolitis

Brief summary: Prospective observational study of patients hospitalized with bronchiolitis. The objective of our study is to compare the accuracy of commonly used clinical scales for bronchiolitis to predict relevant outcomes.


Eligibility criteria: Inclusion Criteria:

Children eligible for the trial must fulfil all of the following criteria:

1. Children admitted to the hospital with the clinical diagnosis of acute bronchiolitis, which is defined as an apparent viral respiratory tract infection associated with airway obstruction manifested by at least one of following symptoms:

* Tachypnoea (WHO definition).
* Increased respiratory effort manifested as follows:

  1. Nasal flaring;
  2. Grunting;
  3. Use of accessory muscles;
  4. Intercostal and/or subcostal chest wall retractions;
  5. Apnoe.
* Crackles and/or wheezing. 2. Aged 5 weeks - 24 months old.

Exclusion Criteria:

1. Diagnosis or suspicion of asthma.

Primary outcomes:
measure: Number of participants requiring oxygen supplementation
timeFrame: From admission to hospital discharge up to 2 weeks
measure: Duration of oxygen supplementation
timeFrame: From admission to hospital discharge up to 2 weeks
measure: The time until the infant will be assessed as being 'fit for discharge'
timeFrame: From admission to hospital discharge up to 2 weeks
measure: Worsening of clinical status, including the following
timeFrame: From admission to hospital discharge up to 2 weeks
measure: Adverse events, especially incidence of pneumonia
timeFrame: From admission to hospital discharge up to 2 weeks
measure: Hospital length of stay
timeFrame: From admission to hospital discharge up to 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Trzebnica
country: Poland
facility: Szpital im. Św. Jadwigi Śląskiej
Study officials:
References:
Clinical trial NCT00264459: Safety and Efficacy of a Sublingual Specific Immunotherapy With an Extract of a Six Grass Pollen Mixture
Official title: A Multicentre, Placebo-controlled, Double-blind Study to Evaluate Efficacy and Safety of a Perennial Sublingual Specific Immunotherapy With a Liquid Formulation of an Extract of a Six Grass Pollen-mixture in Patients With Clinically Relevant Grass Pollen Sensitivity.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Grass Pollen Allergy
Keywords: Sublingual immunotherapy
Rhinoconjunctivitis
Rhinitis
Asthma
Lead sponsor: Allergopharma GmbH & Co. KG
Sponsor class: INDUSTRY
First posted: 2005-12-13
Enrollment: 160
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: The trial is performed to asses efficacy and safety of a sublingual extract of a six grass pollen mixture


Eligibility criteria: Inclusion Criteria:

Rhinitis, Rhinoconjunctivitis, Positive Rast result to grass pollen, Positive skin prick test to grass pollen, Positive specific provocation to grass pollen,

Exclusion Criteria:

Serious chronic diseases, Other perennial allergies

Primary outcomes:
measure: Symptom and Medication Score (SMS)
timeFrame: 1.5 years of therapy
Secondary outcomes:
measure: Visual Rating Scale
timeFrame: 1.5 years
Other outcomes:
Locations:
city: Reinbek
country: Germany
facility: Allergopharma GmbH & Co. KG
Study officials:
name: Ludger Klimek, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Worm M. Efficacy and tolerability of high dose sublingual immunotherapy in patients with rhinoconjunctivitis. Eur Ann Allergy Clin Immunol. 2006 Dec;38(10):355-60.
citation: Pfaar O, Klimek L. Efficacy and safety of specific immunotherapy with a high-dose sublingual grass pollen preparation: a double-blind, placebo-controlled trial. Ann Allergy Asthma Immunol. 2008 Mar;100(3):256-63. doi: 10.1016/s1081-1206(10)60451-6.
Clinical trial NCT04996459: Tislelizumab in the Systematic Treatment of Advanced Hepatocellular Carcinoma
Official title: Real-world Study of Tislelizumab in the Systematic Treatment of Advanced Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatocellular Carcinoma
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2021-08-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients registrated and treated with Tislelizumab at least once were included in the efficacy analysis population as well as the safety analysis population.

Brief summary: Study purpose: To evaluate the efficacy and safety of Tislelizumab in combination with advanced hepatocellular carcinoma in the real world; Study design: Non-intervention, single center, case registration, real-world study; Number of registrations: 40;

Source of data: This project is a non-interventionary real world case follow-up registration. All registration data are from real clinical practice cases. The collected data include the following requirements:

1. Age ≥18 years old;
2. Unresectable hepatocellular carcinoma confirmed by histological examination or clinical diagnosis;
3. Plan or have received systemic therapy combined with Tiralizumab;
4. No participation in other clinical studies;
5. Access to Tislelizumab treatment and other clinical records; Primary endpoint: Overall response rate; Secondary endpoint: Disease control rate, progress free survival, overall survival, safety; Exploratory endpoint: To explore the predictive value of multiple Biomarker combinations, such as PD-L1, TMB, MSI, DDR, POLE/POLD, in HCC immunotherapy response.


Eligibility criteria: This project is a non-interventionary real world case follow-up registration. All registration data are from real clinical practice cases. The collected data include the following requirements:

1. Age ≥18 years old;
2. Unresectable hepatocellular carcinoma confirmed by histological examination or clinical diagnosis;
3. Plan or have received systemic therapy combined with Tislelizumab;
4. No participation in other clinical studies;
5. Access to Tislelizumab treatment and other clinical records.

Primary outcomes:
measure: overall response rate
timeFrame: 6 weeks
Secondary outcomes:
measure: disease control rate
timeFrame: 6 weeks
measure: progress free survival
timeFrame: 6 weeks
measure: overall survival
timeFrame: 6 weeks
measure: Safety (the incidence of adverse events and serious adverse events)
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
affiliation: FUSCC
name: Lu Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03341559: Spatial Frequency Domain Imaging (SFD) for Assessment of Diabetic Foot Ulcer Development and Healing
Official title: Spatial Frequency Domain Imaging (SFD) for Assessment of Diabetic Foot Ulcer Development and Healing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Foot Ulcer
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Modulated Imaging Inc.
First posted: 2017-11-14
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male or female patients at University of Southern California diagnosed with a Diabetic Foot Ulcer

Brief summary: This study is designed to evaluate the ability of Spatial Frequency Domain Imaging (SFDI) to measure perfusion in lower extremities for prediction of both healing and formation of diabetic foot ulcers.

The investigators will perform longitudinal imaging (for 12 months) in two cohorts of subjects


Eligibility criteria: Inclusion Criteria:

I. Will be followed up in clinic on monthly basis for the next 12 months per standard of care II. Belong to one of the two target groups

1. Subjects with an existing diabetic foot ulcer
2. Subjects determined "at risk" for an ulcer

Exclusion Criteria:

1. History of heart failure
2. Rheumatoid arthritis
3. Pregnant or lactating women

Primary outcomes:
measure: Perfusion in lower extremities
timeFrame: 12-month
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Keck Medical Center of USC
state: California
Study officials:
References:
citation: Murphy GA, Singh-Moon RP, Mazhar A, Cuccia DJ, Rowe VL, Armstrong DG. Quantifying dermal microcirculatory changes of neuropathic and neuroischemic diabetic foot ulcers using spatial frequency domain imaging: a shade of things to come? BMJ Open Diabetes Res Care. 2020 Nov;8(2):e001815. doi: 10.1136/bmjdrc-2020-001815.
Clinical trial NCT02105259: Internet-delivered Psychodynamic Therapy for Social Anxiety Disorder (SOFIA)
Official title: Internet-delivered Psychodynamic Therapy for Social Anxiety Disorder: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety Disorder
Keywords: Test
psychodynamic
Internet-delivered psychodynamic treatment
patients with social anxiety disorder
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
Collaborators: name: Karolinska Institutet
name: Stockholm University
First posted: 2014-04-07
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall aim of this study is to develop and test a psychodynamic Internet--delivered psychological treatment for patients with social anxiety disorder and compare its efficacy to a waiting list.

Detailed description: Participants with social anxiety disorder (MINI telephone interview) will be recruited via mass media and randomly allocated to psychodynamic Internet--delivered psychological treatment or to a waiting list control condition.

Eligibility criteria: Inclusion Criteria:

* Social anxiety disorder as diagnosed by the MINI diagnostic interview

Exclusion Criteria:

* Severe depression

Primary outcomes:
measure: Liebowitz Social Anxiety Scale
timeFrame: Baseline and End of treatment (10 weeks)
Secondary outcomes:
measure: Patient Health Questionnaire Depression 9 item
timeFrame: Baseline
measure: Patient Health Questionnaire Depression 9 item
timeFrame: End of treatment (10 weeks)
measure: Patient Health Questionnaire Anxiety 7 item
timeFrame: Baseline
measure: Patient Health Questionnaire Anxiety 7 item
timeFrame: End of treatment (10 weeks)
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Department of Behavioural Sciences and Learning, Linköping University
Study officials:
affiliation: Linkoeping University
name: Gerhard Andersson
role: PRINCIPAL_INVESTIGATOR
References:
citation: Johansson R, Hesslow T, Ljotsson B, Jansson A, Jonsson L, Fardig S, Karlsson J, Hesser H, Frederick RJ, Lilliengren P, Carlbring P, Andersson G. Internet-based affect-focused psychodynamic therapy for social anxiety disorder: A randomized controlled trial with 2-year follow-up. Psychotherapy (Chic). 2017 Dec;54(4):351-360. doi: 10.1037/pst0000147.
Clinical trial NCT01277159: Duration of Analgesia After Popliteal Fossa Nerve Blockade: Effects of Dexamethasone and Buprenorphine
Official title: Duration of Analgesia After Popliteal Fossa Nerve Blockade: Effects of Dexamethasone and Buprenorphine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients Undergoing Ankle Surgery
Keywords: Analgesia
Duration
Popliteal Fossa Nerve Block
Dexamethasone
Buprenorphine
Additives
Ankle surgery
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2011-01-14
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients scheduled to go home after ankle surgery at HSS typically receive a sciatic nerve block in the popliteal fossa and oral analgesic tablets (such as Percocet). Popliteal fossa nerve blockade has reduced pain for these patients (YaDeau et al, Anesth Analg 2008;106:1916-20), but unfortunately the patients still often experience moderate to severe pain after the block wears off. The investigators wish to study two additives that may prolong the period of analgesia provided by the nerve block. The additives will be studied in the context of a standardized postoperative multimodal analgesic pathway.

Primary outcome:

Does adding dexamethasone and / or buprenorphine prolong the analgesia provided by a popliteal fossa nerve block?


Eligibility criteria: Inclusion Criteria:

1. Patients of Dr Levine or Dr Roberts.
2. Scheduled for discharge from HSS after foot or ankle surgery.
3. A single-injection popliteal fossa nerve block is judged appropriate.
4. Surgery confined to foot and ankle (no iliac crest bone graft planned - iliac aspirate is not an exclusion criterion).
5. Patients aged 18-75 years.

Exclusion Criteria:

* Surgery that will cause pain at sites outside the distal lower extremity (e.g. iliac crest bone graft).
* Bilateral surgery
* Chronic pain (defined as regular use of opioid analgesics for \> 3 months).
* Chronic use of steroids (defined as regular use of steroids for \> 3 months).
* Contraindication to performance of the popliteal fossa nerve block with 30 cc 0.25% bupivacaine with clonidine (e.g. alleged bupivacaine sensitivity, low body weight, clonidine allergy, etc.).
* Contraindications to dexamethasone or buprenorphine (e.g. allergy, Insulin Dependent Diabetes Mellitus, etc.)
* Inability of the patient to describe postoperative pain (e.g. psychiatric disorder, dementia).
* Non-English speaking patients (the questionnaire is in English, and translations would have to be separately validated)

Primary outcomes:
measure: Time it Takes for Nerve Block to Wear Off
timeFrame: up to 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Michael Urban
role: PRINCIPAL_INVESTIGATOR
References: