louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00463619: Follow-up Study With Retarded Release Phosphatidylcholine in Ulcerative Colitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2007-04-20
Enrollment: 132
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from previous studies with retarded release phosphatidylcholine

Brief summary: Follow-Up Study with Retarded Release Phosphatidylcholine in Ulcerative Colitis

Objectives:

The objective of the study is to evaluate the follow up of patients treated with retarded release phosphatidylcholine in three controlled, randomized studies.

Main question is to investigate whether treatment with phosphatidylcholine could spare patients the intake of steroids and immunosuppressants without clinical deterioration.

Study population:

* Retarded release phosphatidylcholine in chronic-active ulcerative colitis.
* Retarded release phosphatidylcholine in steroid dependent ulcerative colitis.
* Dose finding study for retarded release phosphatidylcholine

Outcome parameters:

Definition of remission:

1. SCCAI \<2,5
2. Likert scale: grade 1 or 2
3. subjective impression of remission: yes/no
4. no blood in stool

Definition of relapse:

1. subjective impression: yes/no
2. SCCAI ≥ 5
3. blood in stool

Definition of low clinical activity: SCCAI \< 5

Primary endpoint:

sparing effect of steroids and/or immunosuppressants by rPC in chronic active UC.

Secondary endpoints

1. maintenance of continuous remission
2. improvement of disease activity: a. clinical activity (SCCAI) b.life quality (SIBDQ-D) c.Likert Score
3. relapse rate: a. time to first relapse b. clinical activity during relapses c. number of relapses in relation to length of treatment


Eligibility criteria: Inclusion Criteria:

* Patients from previous studies with retarded release phosphatidylcholine

Exclusion Criteria:

* patients with less then 6 weeks follow-up after end of initial study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University Heidelberg - Dep. Gastroenterology
Study officials:
affiliation: University Heidelberg - Gastroenterology
name: Max Karner, MD
role: STUDY_CHAIR
affiliation: Heidelberg University
name: Verena Schmieg, Cand. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01317719: Prospective Biceps Study
Official title: Prospective Biceps Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Biceps Tendon Rupture
Keywords: Rupture of Distal Bicep Tendon
Lead sponsor: West Penn Allegheny Health System
Sponsor class: OTHER
First posted: 2011-03-17
Enrollment: 15
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: Patients who have received primary distal biceps repair by Dr. Schmidt

Brief summary: The primary goal of this study is to determine if surgical repair of the distal biceps fully restores the supination strength of the forearm. Secondarily, the investigators want to examine the insertion site location of the tendon and determine if it correlates with the patients' functional outcome as determined by Disabilities of the Arm, Shoulder, and Hand (DASH), Visual Analog Pain Scale (VAPS), and isometric supination torque testing.


Eligibility criteria: Inclusion Criteria:

* primary distal biceps repair with endobutton

Exclusion Criteria:

* any ipsilateral wrist, forearm, or elbow condition
* any contraindication to having an MRI

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Allegheny Imaging of McCandless
state: Pennsylvania
Study officials:
affiliation: WPAHS
name: Christopher C Schmidt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04899219: A Study to Investigate the Pharmacokinetics of ACT-1014-6470 in Subjects With Severe Renal Impairment Compared to Control Subjects
Official title: An Open-label, Single-dose Study to Investigate the Pharmacokinetics of ACT-1014-6470 in Subjects With Severe Renal Impairment Compared to Control Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Idorsia Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2021-05-24
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective, open-label, single-dose, parallel-group, Phase 1 study.
Primary purpose: OTHER

Brief summary: An open-label, single-dose study to investigate the pharmacokinetics of ACT-1014-6470 in subjects with severe renal impairment compared to control subjects


Eligibility criteria: Inclusion Criteria:

* Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.
* Male or female subject aged at least 18 years at Screening.
* Women of non-childbearing potential (e.g. post-menopausal)

Additional inclusion criteria for subjects with severe renal impairment (Group A).

- Severe renal function impairment as confirmed at Screening based on an estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula of \< 30 mL/min (not on dialysis).

Additional inclusion criteria for control subjects (Group B):

* Normal renal function as confirmed at Screening based on eGFR.
* Each control subject must be matched to the values of one subject with severe renal impairment based on age (±10 years difference allowed), BMI (±15% difference allowed), and sex, determined by results at Screening.

Exclusion Criteria:

- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.

Primary outcomes:
measure: PK of ACT-1014-6470 - Cmax
timeFrame: Blood samples for PK analysis will be drawn at various time points (total duration: up to 6 days in Group A, up to 4 days in Group B).
Secondary outcomes:
Other outcomes:
measure: PK of ACT-1014-6470 - Tmax
timeFrame: Blood samples for PK analysis will be drawn at various time points (total duration: up to 6 days in Group A, up to 4 days in Group B).
measure: Group B (control subjects): PK of ACT-1014-6470 - AUC0-inf
timeFrame: Blood samples for PK analysis will be drawn at various time points (total duration: up to 6 days in Group A, up to 4 days in Group B).
measure: Group B (control subjects): PK of ACT-1014-6470 - T1/2
timeFrame: Blood samples for PK analysis will be drawn at various time points (total duration: up to 6 days in Group A, up to 4 days in Group B).
Locations:
city: Munich
country: Germany
facility: APEX GmbH
Study officials:
References:
Clinical trial NCT04739319: Project AMD: Comprehensive Characterisation of Age-Related Macular Degeneration and Its Progression
Official title: Project AMD: Comprehensive Characterisation of Age-Related Macular Degeneration and Its Progression
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Age Related Macular Degeneration
Geographic Atrophy
AMD
Age-related Macular Degeneration
Keywords: Age Related Macular Degeneration
Geographic Atrophy
Drusen
Macular disease
Lead sponsor: Center for Eye Research Australia
Sponsor class: OTHER
First posted: 2021-02-04
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People in Australia aged 18 years or older with AMD or healthy controls, willing and able to provide informed consent, and willing to accept the study requirements.

Brief summary: Age-related macular degeneration (AMD) is the leading cause of irreversible vision loss worldwide, and nearly two million Australians have some signs of AMD. This proposed project is a prospective, observational study that seeks to to understand the underlying aetiology of AMD, factors associated with differences between age-related macular degeneration (AMD) phenotypes or severities, or between AMD and healthy individuals. It also seeks to understand the natural history of AMD progression and the factors associated with the rate of progression. In this project, the disease phenotype, genotype and severity and rate of progression will be determined based on non-invasive clinical imaging or functional assessment of the retina, from obtaining biological samples from the participants, or from patient-reported outcomes.


Eligibility criteria: Inclusion Criteria:

1. 18 years of age or older; and
2. either AMD (defined as having at least a medium druse \>63 um), or having eyes with normal ageing changes (including small drusen ≤63 um) or no abnormalities as control participants

Exclusion Criteria:

1. ocular or systemic conditions other than AMD that could compromise retinal assessment or assessment of AMD and its progression; or
2. any participant with any mental or physical impairment that prevents them from signing an informed consent form or participating in this study.

Primary outcomes:
measure: Investigate the underlying aetiology of Age-Related Macular Degeneration
timeFrame: Up to 20 years
measure: Characterise the natural history of Age-Related Macular Degeneration and factors associated with its rate of progression.
timeFrame: Up to 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: East Melbourne
country: Australia
facility: Centre for Eye Research Australia
state: Victoria
Study officials:
References:
Clinical trial NCT02864719: An Intervention for Cardiac Arrest Survivors With Chronic Fatigue
Official title: An Intervention for Cardiac Arrest Survivors With Chronic Fatigue: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Arrest
Cardiac Arrest
Fatigue
Keywords: Heart arrest
Cardiac arrest
Fatigue
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2016-08-12
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary aim was to examine the feasibility of an Energy Conservation + Problem Solving Therapy (EC+PST) intervention delivered over the telephone and to evaluate the preliminary intervention effect on fatigue impact in daily activities in post-cardiac arrest (CA) adults with chronic fatigue.

Detailed description: The primary aim was to examine the feasibility of recruiting and retaining participants for an Energy Conservation + Problem Solving Therapy (EC+PST) intervention delivered over the telephone, to evaluate the acceptability of the intervention, and to assess the appropriateness of the outcome measures. The secondary aim was to evaluate the preliminary intervention effect on fatigue impact, activity performance, and participation in daily activities in post-cardiac arrest (CA) adults with chronic fatigue.

Eligibility criteria: Inclusion Criteria:

* At least 3 months post-cardiac arrest
* Presence of moderate-to-severe fatigue: ≥ 4 score on the Fatigue Severity Scale
* Availability of landline telephone or cell phone
* Living within 150 miles of the University of Pittsburgh, Oakland
* Functional English fluency and literacy
* Intact cognition
* Community living

Primary outcomes:
measure: Number of people who completed their study participation
timeFrame: Week 5
measure: Number of participants who successfully identified and solved fatigue-related problems
timeFrame: Week 5
measure: Client Satisfaction Questionnaire - 8
timeFrame: Week 5
measure: Understanding of Materials Scale
timeFrame: Week 5
Secondary outcomes:
measure: Modified Fatigue Impact Scale
timeFrame: Week 0 and Week 5
measure: Fatigue Severity Scale
timeFrame: Week 0 and Week 5
measure: Patient-Reported Outcomes Measurement Information System Fatigue Scale
timeFrame: Week 0 and Week 5
measure: Performance Assessment of Self-Care Skills - Self-report (PASS-SR)
timeFrame: Week 0 and Week 5
measure: Functional Activities Questionnaire
timeFrame: Week 0 and Week 5
measure: Participation Objective, Participation Subjective (POPS)
timeFrame: Week 0 and Week 5
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00042419: Work and Health Disparities Among Rural Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tendonitis
Carpal Tunnel Syndrome
Cumulative Trauma Disorders
Overuse Syndrome
Keywords: Industrial Injuries
Tendonitis
Assembly Line
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
First posted: 2002-08-01
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: NATURAL_HISTORY
Time perspective: PROSPECTIVE

Brief summary: This is a study of the effects of fast paced assembly line work on women. We are studying problems women in poultry processing have with their muscles, tendons, and nerves as well as acute injuries they have in the workplace. We are also studying how their work affects the quality of their lives.


Eligibility criteria: Women employed in poultry processing less than 9 months

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
References:
Clinical trial NCT02174419: Study of Nalbuphine HCl ER Tablets in Patients With Prurigo Nodularis
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel, 3-Arm Study of the Safety and Anti-Pruritic Efficacy of Nalbuphine HCl ER Tablets in Prurigo Nodularis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Prurigo Nodularis
Nodularis Prurigo
Prurigo
Pruritus
Keywords: Itch
Chronic Itch
nalbuphine
Lead sponsor: Trevi Therapeutics
Sponsor class: INDUSTRY
First posted: 2014-06-25
Enrollment: 62
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: The primary objectives of the study are to evaluate the effects of two doses of nalbuphine HCl ER tablets on the change from baseline in the worst itch Numerical Rating Scale (NRS) in patients with prurigo nodularis and to evaluate the safety and tolerability in the study population.


Eligibility criteria: Inclusion Criteria:

* Subject suffering from generalized prurigo nodularis
* Have demonstrated pruritus intensity during screening
* Male or female who are at least 18 years old at the time of consent

Exclusion Criteria:

* Subject has chronic pruritus resulting from other conditions
* Subject has a history of substance abuse within the past year
* Subject has a known drug allergy to opioids
* Subject is a pregnant or lactating female

Primary outcomes:
measure: Change From Baseline to the Evaluation Visit (Week 10) in Itch on the 0-10 Numerical Rating Scale
timeFrame: Baseline, Week 10
Secondary outcomes:
measure: Change From Baseline to the Evaluation Visit (Week 10) in the Mean Itch on the 0-10 Numerical Rating Scale
timeFrame: Baseline, Week 10
Other outcomes:
measure: Change From Baseline to the Evaluation Visit (Week 10) in the Verbal Rating Scale
timeFrame: Baseline, Week 10
Locations:
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Münster
country: Germany
facility: University of Münster
city: Wroclaw
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
state: Dolnoslaskie
Study officials:
affiliation: Trevi Therapeutics
name: Chief Development Officer
role: STUDY_DIRECTOR
References:
citation: Stander S, Zeidler C, Pereira M, Szepietowski JC, McLeod L, Qin S, Williams N, Sciascia T, Augustin M. Worst itch numerical rating scale for prurigo nodularis: a psychometric evaluation. J Eur Acad Dermatol Venereol. 2022 Apr;36(4):573-581. doi: 10.1111/jdv.17870. Epub 2022 Feb 14.
citation: Weisshaar E, Szepietowski JC, Bernhard JD, Hait H, Legat FJ, Nattkemper L, Reich A, Sadoghi B, Sciascia TR, Zeidler C, Yosipovitch G, Stander S. Efficacy and safety of oral nalbuphine extended release in prurigo nodularis: results of a phase 2 randomized controlled trial with an open-label extension phase. J Eur Acad Dermatol Venereol. 2022 Mar;36(3):453-461. doi: 10.1111/jdv.17816. Epub 2021 Dec 1.
Clinical trial NCT06541119: Effect of Selective Strengthening of Peroneus Longus on Pain , Joint Alignment and Foot Function in Hallux Valgus
Official title: Effect of Selective Strengthening of Peroneus Longus Muscles on Pain Joint Alignment and Foot Function in Hallux Valgus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hallux Valgus
Keywords: Peroneus longus
Hallux valgus angle HVA
Kinovea software
Foot function index
Hallux pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-08-07
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: Purpose of this study is to measure Change in Hallux valgus angle (HVA )as measured by kinovea software Change in pain as measured by numerical pain rating scale (NPRS) Change in function as measured by Foot function index (FFI )Egyptian version With the peroneus longus strengthening exercise versus the use of conventional physical therapy programme in cases of hallux valgus patients


Eligibility criteria: Inclusion Criteria:

* All patients must be diagnosed as having mild to moderate Hallux valgus (with Hallux valgus angle between 15-40 degrees)
* patients aging between 18-60 .
* patients must report pain and limited function .
* patients must report that they are not undergoing physiotherapy , not using orthosis , dynamic splinting exercises for Hallux valgus

Exclusion Criteria:

* Patients diagnosed with systematic diseases such as rheumatoid arthritis .
* Cognitive or mental illness.
* Hallux rigidus or limitus .
* History of surgery to foot of Hallux .
* Previous use of foot orthosis .

Primary outcomes:
measure: Hallux valgus angle HVA
timeFrame: Baseline , 6 weeks (after study completion )
measure: Level of pain
timeFrame: Baseline , 6 weeks after study completion
measure: Foot function
timeFrame: Baseline , 6 weeks after study completion
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo university
Study officials:
References:
Clinical trial NCT02154919: Non-culprit Vessels for ST-Segment Elevation Myocardial Infarction
Official title: Conservative Pharmacotherapy Versus Staged Percutaneous Coronary Intervention on Non-culprit Vessels for ST-Segment Elevation Myocardial Infarction Patients With Multivessel Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Conservative Pharmacotherapy
Staged Percutaneous Coronary Intervention
Non-culprit Vessels
ST-Segment Elevation Myocardial Infarction
Lead sponsor: Beijing Shijitan Hospital, Capital Medical University
Sponsor class: OTHER
First posted: 2014-06-03
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: STEMI patients after culprit vessels treated by PPCI

Brief summary: To compare the different effect of conservative pharmacotherapy and Staged Percutaneous Coronary Intervention (SPCI) on significant non-culprit lesions in patients with ST-segment elevation myocardial infarction (STEMI) at presentation remains controversial


Eligibility criteria: Inclusion Criteria:

* age 18 to 75 with continuous ischemic chest pain for ≥ 30 minutes and ST-segment of electrocardiographic leads between V2 and V3 elevated ≥ 0.2 mV (or ≥ 0.1 mV in ≥ 2 other continuous electrocardiographic leads), cardiac troponin I (cTn I) elevation of \> 0.05 ng/ml, coronary arteriography within 12 hours after the onset of symptoms indicating lesion in culprit vessel with thrombolysis in myocardial infarction (TIMI) flow grade 0 to 1, merely underwent PPCI. Additionally, coronary arteriography corroborates lesions in non-culprit vessel (Besides the culprit vessel, there are ≥ 70% stenoses in one or more coronary vessels in which diameters were ≥ 2 mm).

Exclusion Criteria:

* left main coronary artery disease, cardiogenic shock, complete left bundle branch block (CLBBB) PPCI treated culprit and non-culprit vessels, PPCI failure patients with postsurgical haemodynamic instability or spontaneous ischemia, ≥ 70% stenoses of vessels remained during the hospitalization after staged PCI, history of PCI or Coronary Artery Bypass Grafting (CABG), history of chronic cardiac failure, bleeding diathesis, prior administration of thrombolytic therapy, known thrombopenia or leucopenia, sever liver and kidney dysfunction, active infection, immune system and connective tissue diseases, known contraindications to aspirin or heparin, life expectancy \< 1 year, had major procedure within 3 months, uncontrolled hypertension, ischemic stroke within 30 days, hemorrhagic stroke, intracranial diseases including and arteriovenous malformation, extensive traumatic cerebral infarction within 6 weeks, oral anticoagulant therapy, severe myocardial infarction related complications and perioperative death

Primary outcomes:
measure: Major Adverse Cardiovascular Events
timeFrame: 360days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Shijitan Hospital
state: Beijing
Study officials:
References: