louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02103725: A Multi-Centre Clinical Trial to Evaluate a Left-Right Design in Adults With Mild to Moderate Atopic Dermatitis
Official title: A Phase I, Multi-Centre, Randomised, Vehicle-Controlled, Double-Blinded, Explorative Clinical Trial to Evaluate a Left-Right Design in Adults With Mild to Moderate Atopic Dermatitis Over a Treatment Period of Three Weeks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atopic Dermatitis
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2014-04-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to validate a left-right design with respect to detecting a difference in efficacy after 3 weeks of treatment between an active treatment and a vehicle in adults with mild to moderate atopic dermatitis


Eligibility criteria: Inclusion Criteria:

* 1. Male and female subjects, 18 years or older
* 2. Subject with atopic dermatitis with mild to moderate disease severity
* 3. Two symmetrical and comparable atopic dermatitis treatment areas
* 4. Female volunteers of childbearing potential must either be surgically sterile or agree to use a reliable method of contraception

Exclusion Criteria:

* 1. Any condition in the target areas that in the opinion of the investigator could interfere with clinical assessments, e.g. acne, infection, rash other than atopic dermatitis, sunburn, hyper- or hypopigmentation, scars
* 2. Dark-skinned persons whose skin colour prevents reliable clinical assessments
* 3. Any permanent (or transient within 28 days prior to dosing) disease that may interfere with the subjects safe participation in the trial, with the subjects ability to participate in the trial or with the clinical assessments
* 4. Pregnancy or breastfeeding

Primary outcomes:
measure: Evaluation of the treatment effect defined as total sign score on the treated area at end of the 3 weeks treatment period
timeFrame: 3 weeks
Secondary outcomes:
measure: Incidence of adverse events during the 3 weeks treatment period
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: bioskin GmbH
Study officials:
References:
Clinical trial NCT01050725: Pilot Study of Biomarkers for Radiation Therapy
Official title: Investigating Proteomic Biomarkers of Radiation Therapy Outcome: A Pilot Study
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Cancer
Keywords: proteome
biomarkers
radiotherapy
cancer
Lead sponsor: Benaroya Research Institute
Sponsor class: OTHER
Collaborators: name: Virginia Mason Hospital/Medical Center
name: Fred Hutchinson Cancer Center
First posted: 2010-01-15
Enrollment: 100
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: patients undergoing radiation for selected malignancies, including head and neck, lung, esophageal, rectal, cervical and prostate cancers.

Brief summary: The purpose of this study is to determine whether specific assays of DNA damage repair proteins can be used in patients undergoing radiation therapy. The ultimate goal of this research is to develop clinically useful biomarkers from blood samples that could be used to customize radiation treatment for individuals, leading to reduced side effects and improved outcomes.


Eligibility criteria: Inclusion Criteria:

* patients \> 18 years of age with primary lung, esophageal or rectal cancer receiving neo-adjuvant chemoradiotherapy before planned resection
* patients with clinically localized prostate cancer receiving definitive radiation therapy with external beam treatment. brachytherapy as a boost and/or hormonal therapy are allowed.
* patients with head and neck, lung, esophageal or cervical cancer who will receive definitive radiotherapy

Exclusion Criteria:

* prior history of chemotherapy given within 6 months before enrollment.
* prior radiotherapy or radionuclide treatment and/or brachytherapy within 6 months prior to enrollment.
* unwillingness to comply with tests, protocol, or informed consent.
* concurrent enrollment on any protocol that would require non-compliance with treatment procedures.
* chemotherapy required within 2 hours following first dose of XRT.
* PET scan done within 48 hours of first blood draw.
* nuclear medicine exposure within 4 days prior to first draw.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
Study officials:
affiliation: Virginia Mason Hospital/Medical Center
name: Kas R Badiozamani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00795925: Dose-Escalating Study of Propiverine Hydrochloride in Children Suffering From Overactive Bladder
Official title: Dose-Escalating Study of Propiverine Hydrochloride (Mictonetten®) in Children Suffering From Frequency-Urgency-Syndrome and Urinary Incontinence Indicative of Detrusor Overactivity (Overactive Bladder)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Overactive Bladder
Keywords: propiverine
anticholinergics
urinary incontinence
overactive bladder
children
dose-finding in children aged 5-10 years
Lead sponsor: APOGEPHA Arzneimittel GmbH
Sponsor class: INDUSTRY
First posted: 2008-11-21
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no

Brief summary: The open-label dose-escalating two-centre study was designed to assess the pharmacokinetics as well as safety, tolerability and efficacy parameters of propiverine in patients 5-10 years of age suffering from frequency-urgency-syndrome and urinary incontinence indicative of detrusor overactivity (overactive bladder) for determination of the recommended dose in children.


Eligibility criteria: Main Inclusion Criteria:

* Micturition Frequency ≥6 micturitions during awake period
* Urge Incontinence Episodes ≥1/week
* Urgency Episodes ≥1/day

Main Exclusion Criteria:

* Contraindication to anticholinergic therapy
* Repeated measurement of Post Void Residual ≥20 mL
* Nocturnal Enuresis
* Clinically significant cardiovascular, hepatic, renal, gastrointestinal or hematological disease, psychiatric disorder or diabetes insipidus
* Anatomical abnormalities of the urinary tract

Primary outcomes:
measure: Pharmacokinetic parameters of propiverine and its main metabolite propiverine N-oxide at steady state: Ctrough, Cmax, Tmax, AUC0-8h. Children were separated into 3 groups.
Secondary outcomes:
measure: Tolerability of propiverine. Efficacy: Changes from baseline: voiding frequency, incontinence and urgency episodes,voided volume. Safety: Post Void Residual (PVR),adverse events,laboratory values (urine, blood), ECG.
timeFrame: two weeks
Other outcomes:
Locations:
Study officials:
affiliation: Drottning Silvias ,Barn- och ungdomssjukhus, SU/Östra,416 85 Göteborg
name: Professor Ulla Sillen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Siegmund W, Sillen U, Lackgren G, Schnabel F, Murtz G, Feustel C. Pharmacokinetics and pharmacodynamics of propiverine in children aged between 5 and 10 years with symptoms of overactive bladder. Clin Pharmacokinet. 2010 May;49(5):335-42. doi: 10.2165/11319990-000000000-00000.
Clinical trial NCT00443625: Phase 1 Study of SK3530 to Investigate of the Effect of Food
Official title: Clinical Trials to Investigate the Influence of Food on Pharmacokinetics of SK3530 in Healthy Male Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Erectile Dysfunction
Keywords: SK3530
Food effect
Pharmacokinetics
Lead sponsor: SK Chemicals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2007-03-06
Enrollment: 15
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study was designed to investigate the food effect of SK3530 on the pharmacokinetics (PKs).

Detailed description: The PDE5 inhibitor, SK3530, is expected to be taken concomitantly with food. The food interaction studies of other PDE5 inhibitors (Viagra, Levitra and cialis) have already accomplished and the results have provided useful information to the patients. The objective of this study is to compare the pharmacokinetics (PKs) of SK3530 and its metabolite (SK3541) under the fasted and fed (low-fat meal and high-fat meal) conditions.

Eligibility criteria: Inclusion Criteria:

* ages 19 to 50
* body weight of (IBM) ± 20%

Exclusion Criteria:

* cardiovascular disease
* color-blindness or weakness

Primary outcomes:
measure: PK parameters - AUC, Cmax, Tmax
Secondary outcomes:
measure: PK parameters-t1/2
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Hospital
name: In-Jin Jang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06497348: Application of an Exercise Program Versus Exercise Plus Manual Therapy in the Treatment of Adhesive Capsulitis.
Official title: Application of an Exercise Program Versus Exercise Plus Manual Therapy in the Treatment of Adhesive Capsulitis.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Capsulitis of Shoulder
Frozen Shoulder
Keywords: "adhesive capsulitis"
"frozen shoulder"
"manual therapy"
"therapeutic exercise"
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2024-07-11
Enrollment: 108
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The evaluation of each group will be carried out in different rooms of the university, a team of 6 physiotherapists divided into two groups, where 3 will evaluate with knowledge of the pathology and the other 3 without knowledge of it.

The experimental group will receive mobilization treatment and exercises, while the control group will receive only exercises. Weekly one-hour sessions will be held, from Monday to Friday, with two times available for each patient. The experimental group, treated by physiotherapists who know the pathology, will be applied Maitland mobilization techniques, focused on passive neural and joint mobilizations. Flexion-extension, abduction-adduction, and external and internal rotation movements will be performed.

The control group, treated by physiotherapists who will blindly evaluate the patients, will only be prescribed exercises, the same as the experimental group.
Primary purpose: TREATMENT

Brief summary: The main objective is to evaluate whether a treatment program combining manual therapy (joint mobilization) and exercise is more effective in the treatment of adhesive capsulitis than an exercise program applied in isolation.

The researchers will compare both groups (experimental group and control group) using the different techniques.

During the sessions, mobility will be evaluated with a goniometer and data will be recorded to monitor progress, maintaining a confidential record of the data.


Eligibility criteria: Inclusion Criteria:

* men and women from 40 to 60 years old, whether or not they carry out physical activity
* intervention through therapeutic exercise and/or joint mobility.

Exclusion Criteria:

* children
* older people
* people with previous shoulder pathology
* people with cognitive impairment who cannot complete questionnaires
* treatment that does not include exercise or joint mobility
* treatment with machines.

Primary outcomes:
measure: evaluation of the improvement of shoulder mobility in patients with adhesive capsulitis by performing by an exercise program, mobilization or boths techniques.
timeFrame: 3-4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Facultad de Enfermeria y Fisioterapia de la Universidad de Alcalá de Henares
Study officials:
References:
Clinical trial NCT01786330: Do Elastic Abdominal Binders Reduce Post Operative Pain and Blood Loss?
Official title: Do Elastic Abdominal Binders Reduce Post Operative Pain and Blood Loss?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Hemorrhage
Pain
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2013-02-07
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a pilot study investigating the use of abdominal binders after cesarean sections. The researchers are testing whether elastic abdominal binders improve postoperative pain control and reduce postoperative blood loss. Blood loss and pain control are both concerns after giving birth. It is hoped that the use of an abdominal binder after giving birth will provide a non-pharmacologic way to to reduce blood loss and manage pain.


Eligibility criteria: Inclusion Criteria:

* Cesarean section at term (at least 39 weeks gestation) scheduled in advance
* Singleton gestation confirmed by ultrasound in the current pregnancy
* Body mass index 20-40 kg/m2 (at first prenatal visit or pre-pregnancy)
* None of these pregnancy complications in the current pregnancy:

  1. bleeding disorder or use of anticoagulants other than low-dose heparin
  2. abnormal placenta (placenta previa or accrete)
  3. Preoperative hemoglobin less than 10 mg/dL
  4. Chorioamnionitis (intrauterine infection)
* No chronic pain syndrome (defined as participating in formal chronic pain management within the past year)
* Able to read English and understand spoken English

Exclusion Criteria:

* Onset of labor prior to time when the cesarean was scheduled
* Complications during performance of cesarean or discovered during cesarean:

  1. placenta accreta, increta, or percreta
  2. vasa previa
  3. cesarean hysterectomy required for severe hemorrhage
  4. organ damage during cesarean (cystotomy, enterotomy, ureteral injury)

Primary outcomes:
measure: Lowest Pain Level Postoperative
timeFrame: 24 hours postoperative
measure: Average Pain Level Postoperative
timeFrame: 24 hours postoperative
measure: Worst Pain Level Postoperative
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: Change in Hemoglobin Concentration
timeFrame: 24 hours from baseline
Other outcomes:
Locations:
city: Wichita
country: United States
facility: Kansas School of Medicine-Wichita
state: Kansas
city: Wichita
country: United States
facility: Wesley Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Zachary Kuhlmann, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zimpel SA, Torloni MR, Porfirio GJ, Flumignan RL, da Silva EM. Complementary and alternative therapies for post-caesarean pain. Cochrane Database Syst Rev. 2020 Sep 1;9(9):CD011216. doi: 10.1002/14651858.CD011216.pub2.
Clinical trial NCT04850248: Scoring Model for Predicting Outcome in Patients With Cardiogenic Shock
Official title: Scoring Model for Predicting Outcome in Patients With Cardiogenic Shock: From Emergency Room to Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiogenic Shock
Keywords: cardiogenic shock
epidemiography
outcome
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-04-20
Enrollment: 999
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will enroll patients with who arrived at the emergency department with cardiogenic shock and subsequently admitted to the cardiac care unit.

Brief summary: This study aims to develop a predictive model for the outcomes of patients with cardiogenic shock

Detailed description: This retrospective observational study will enroll patients with cardiogenic shock admitted to the cardiac care unit. Patient characteristics, clinical events during hospitalization, and laboratory examination findings will be collected and analyzed to determine factors associated with mortality. A nomogram will be developed accordingly and will undergo both internal and external validation.

Eligibility criteria: Inclusion Criteria:

* Patients with cardiogenic shock
* Admitted to the cardiac care unit (CCU)

Exclusion Criteria:

* Non-cardiogenic shock in origin
* Post open heart surgery

Primary outcomes:
measure: Mortality
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Taiwan University Hospital
name: Min-Shan Tsai, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02995148: Sun Protection Factor Assay (343/2016)
Official title: Sun Protection Factor (SPF) Assay UVA Protection Factor Assay (UVAPF) Minimal Persistent Pigment-Darkening Dose (MPPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-12-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility criteria: Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female.
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF (Subject History Form).
* Signed and dated Informed Consent Form
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose).

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnosed by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma, diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.

Primary outcomes:
measure: Minimal Erythema Dose (MED)
timeFrame: Up to 15 minutes
measure: Minimal Persistent Pigment Darkening Dose (MPPD)
timeFrame: Up to 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Union
country: United States
state: New Jersey
Study officials:
References:
Clinical trial NCT00004648: Studies of Hereditary Hemorrhagic Telangiectasia
Official title: Studies of Hereditary Hemorrhagic Telangiectasia: Screening Methods for Pulmonary Arteriovenous Malformations; Prevalence of Pulmonary and Cerebral Arteriovenous Malformations; Prevalence of Cardiac Valve Abnormalities; and Identification of Modifier Genes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Telangiectasia, Hereditary Hemorrhagic
Keywords: genetic diseases and dysmorphic syndromes
hematologic disorders
hereditary hemorrhagic telangiectasia
rare disease
Osler-Rendu-Weber disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: University of Vermont
First posted: 2000-02-25
Enrollment: 65
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: OBJECTIVES: I. Examine screening modalities for pulmonary vascular arteriovenous malformation (PAVM) in individuals with endoglin mutations.

II. Examine the prevalence of cerebral arteriovenous malformations (CAVM) in individuals with hereditary hemorrhagic telangiectasia (HHT).

III. Investigate whether modifier genes exist that determine which individuals with HHT due to an endoglin mutation develop PAVMs and which develop CAVMs.

IV. Investigate the frequency of cardiac valve abnormalities in individuals affected with HHT due to an endoglin mutations.

Detailed description: PROTOCOL OUTLINE: Patients with hereditary hemorrhagic telangiectasia (HHT) undergo 5 different screening methods to determine which method is most effective in detecting arteriovenous malformations (AVM). Patients may participate in more than one screening method.

In part 1, patients undergo 3 different screening techniques (e.g., pulse oximetry, spiral computed tomography (CT), and contrast echocardiography) to detect pulmonary arteriovenous malformations (PAVM).

Patients in part 2 undergo magnetic resonance imaging (MRI) using gadolinium as the contrasting agent for AVM in the brain, known as cerebral arteriovenous malformations (CAVM). For pregnant women, this procedure may only take place if there is clinical evidence that suggests CAVM.

In part 3, Doppler ultrasound is used to screen for hepatic arteriovenous malformations (HAVM). The abdomen of each patient is viewed to detect AVM in the liver.

Patients in part 4 undergo echocardiograms as the screening method used to determine common heart valve abnormalities.

In part 5, blood samples are drawn from patients and analyzed to locate modifier genes as a possibility in determining severity of HHT.

Eligibility criteria: * Osler-Rendu-Weber disease (or hereditary hemorrhagic telangiectasia)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Vermont
name: Alan Guttmacher
role: STUDY_CHAIR
References: