louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05837286: Conservative Treatment of Trigger Finger
Official title: Conservative Treatment of Trigger Finger: Outcomes of a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hand Injuries
Trigger Finger
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The primary objective of this study is to analyze the effectiveness of a nighttime PIP joint extension orthosis to improve pain and restore functional outcomes in TF and comparing two groups of participants with TF, one group receiving a cortisone injection only and the experimental group receiving the nighttime orthosis after cortisone injection using the QuickDASH.
Primary purpose: TREATMENT

Brief summary: This study is to analyze the effectiveness of a nighttime extension orthosis after receiving a cortisone injection for the treatment of trigger finger to improve pain and restore functional outcomes. The investigators hypothesize that the extension orthosis will improve pain and functional outcomes compared to those without a digital night extension orthosis in those with trigger finger at 12 weeks from the injection.

Detailed description: The purpose of the research is to analyze the effectiveness of a proximal interphalangeal joint (PIPJ) extension night orthosis status-post cortisone injection of the first annular pulley for the treatment of trigger finger to improve pain and restore functional outcomes. The investigators hypothesize that the extension orthosis will improve pain and functional outcomes (Quick Dash score) compared to those without a digital night extension orthosis in those with trigger finger at 12 weeks from the injection.

Eligibility criteria: Inclusion Criteria:

* Individuals 18 years old or older are included
* Patients with trigger finger, aka stenosing flexor tenosynovitis
* Status post receiving cortisone injection of the affected digit(s)

Exclusion Criteria:

* Any records flagged with break the glass or research opt out
* Patients with rheumatoid arthritis
* Patients with a history of traumatic injury to the hand
* Cognitive or behavioral problems which would preclude informed consent
* Unable to speak and understand English

Primary outcomes:
measure: Resolution of Trigger Finger Symptoms
timeFrame: 6 Weeks
measure: Resolution of Trigger Finger Symptoms
timeFrame: 12 Weeks
Secondary outcomes:
measure: Change in Pain
timeFrame: 6 weeks
measure: Change in Pain
timeFrame: 12 weeks
measure: Change in Perception of Function
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center Outpatient Rehabilitation Hand Clinic
state: California
Study officials:
References:
Clinical trial NCT04182386: Scandinavian Cohort Study for Optimal Use of Portal Vein Embolization
Official title: Scandinavian Cohort Study for Optimal Use of Portal Vein Embolization
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatic Neoplasm
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2019-12-02
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Scandinavian patients subjected to PVE at 6 hepatobiliary centers during the study period.

Brief summary: Several aspects on the use of portal vein embolization (PVE) are poorly studied and todays recommendations are based on low-grade evidence. In this Scandinavian multicenter cohort study we will study some of the controversial aspects on the use of PVE to try to provide clearer answers on its optimal use. Six tertiary university hospital hepatobiliary units in Sweden, Norway and Denmark participate and contribute with all PVE procedures performed at their units during the study period. We will then study several aspects PVE technique in relation to induced hypertrophy and surgical outcome.


Eligibility criteria: Inclusion Criteria:

* Right-sided PVE

Exclusion Criteria:

* Left-sided PVE

Primary outcomes:
measure: Future liver remnant hypertrophy
timeFrame: Based on radiology around 4 weeks before and after intervention
Secondary outcomes:
measure: Effect of segment 4 embolization on hypertrophy
timeFrame: Based on radiology around 4 weeks before and after intervention
measure: Effect of hyperbilirubinemia on hypertrophy
timeFrame: Based on radiology around 4 weeks before and after intervention
measure: Effect of sarcopenia on hypertrophy
timeFrame: Based on radiology around 4 weeks before and after intervention
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska University Hospital
name: Ernesto Sparrelid, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05626686: An Exploratory Investigation of the Effects of Single Use vs. Reuse Catheters in Intermittent Catheterization
Official title: An Exploratory Investigation of the Effects of Single Use vs. Reuse Catheters in Intermittent Catheterization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2022-11-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The investigation is designed as an open-labelled, single-arm investigation including subjects currently using single use catheters.
Primary purpose: OTHER

Brief summary: The overall aim of the investigation is to investigate the effect of repeated reuse of intermittent urinary catheters and to observe the impact of switch from single use to multiple reuse catheters.

Detailed description: Throughout the investigation, the impact of switch from single use to multiple reuse catheters will be observed and compared with respect to health-related quality of life (HR-QoL), satisfaction, perception, and preference in female and male catheter-users, who use clean intermittent catheterization (CIC) for bladder management.

Furthermore, the investigation intends to identify microbial contamination of reused catheters and compare proportions to a control single use catheter.

Eligibility criteria: Inclusion Criteria:

1. ≥18 years of age and has full legal capacity
2. Signed informed consent form
3. Use clean intermittent catheterization to the greatest extent possible (at least three times daily) for at least the last 1 month prior to inclusion
4. Ability (assessed by the investigator) and willingness to participate in a 4-week study period with at least three catheterizations a day using the investigational test product
5. Self-catheterize using a single use hydrophilic coated catheter for at least 1 month prior to inclusion

Exclusion Criteria:

1. Participation in any other clinical intervention study during this investigation
2. Previous participation in this investigation
3. Any known allergies towards ingredients in the investigational device
4. Symptoms of UTI at time of inclusion, as judged by the investigator
5. Antibiotic treatment within 2 weeks prior to the Baseline visit (V1)
6. Pregnancy
7. Breastfeeding

Primary outcomes:
measure: Change in Health-related Quality of Life From Baseline (Visit 1) to Termination (Visit 5), Measured by the Intermittent Self-Catheterization Questionnaire Index Score.
timeFrame: Baseline (day 0) and Termination (day 28).
Secondary outcomes:
measure: Adverse Events
timeFrame: 28 days
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense Universitetshospital
Study officials:
affiliation: Odense Universitetshospital
name: Karin Andersen
role: PRINCIPAL_INVESTIGATOR
affiliation: Zealand University Hospital
name: Nessn Azawi
role: PRINCIPAL_INVESTIGATOR
affiliation: Ålborg Universitetshospital
name: Brian Kloster
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03255486: Identification and Evaluation of Biomarkers of Resistance to Neoadjuvant Chemotherapy (IDEA SEIN)
Official title: Identification and Evaluation of Biomarkers of Resistance to Neoadjuvant Chemotherapy and Establishment of Preclinical Models of Resistance in Locally Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2017-08-21
Enrollment: 164
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Biomarkers of resistance to neoadjuvant chemotherapy in locally advanced breast cancer

Detailed description: Identification and evaluation of biomarkers of resistance to neoadjuvant chemotherapy and establishment of preclinical models of resistance in locally advanced breast cancer

Eligibility criteria: Inclusion Criteria:

* proven invasive breast adenocarcinoma (cytology and / or biopsy).

  * locally advanced stage (tumor size greater than 2 cm).
  * neoadjuvant chemotherapy indication validated RCP
  * Patient eligible for neoadjuvant chemotherapy.
  * Performance Index according to WHO or less 1.
  * Patient aged 18 years and older.
  * Being affiliated to a social security scheme or an equivalent scheme of social protection
  * Obtaining signed informed consent, and that before any specific prequalification testing.

Exclusion Criteria:

* presence of metastatic disease at diagnosis.

  * Breast Cancer inflammatory.
  * rare histologic subtypes (non ductal lobular and not).
  * Other cancer (except basal cell skin carcinoma and cancer of the cervix in situ adequately treated and curative) treated in the previous 5 years.
  * Patient pregnant or nursing or of childbearing age without effective contraception.
  * Breast cancer in men.
  * legal incapacity or limited legal capacity. medical or psychological conditions allowing the subject to complete the study or to sign the consent (art. L.1121-6, L.1121-7, L.1211-8, L1211-9).

Primary outcomes:
measure: predictive molecular abnormalities assessment
timeFrame: up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Institut régional du Cancer de Montpellier
Study officials:
affiliation: Institut régional du Cancer de Montpellier
name: Marc Ychou
role: STUDY_DIRECTOR
References:
Clinical trial NCT01610986: Effects of Glucose-fructose Drinks During Training on Lactate Transport
Official title: Effects of Glucose-fructose Drinks During Training on Lactate Transport and Oxidation and on Endurance Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Normal Physiology on Healthy Subjects
Keywords: Fructose
Exercise
Lactic acid
Monocarboxylic Acid Transporters
Lead sponsor: University of Lausanne
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire Vaudois
First posted: 2012-06-04
Enrollment: 17
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine whether glucose-fructose intake during training increases lactate transport and oxidation and improve endurance performance.

Detailed description: The study will enroll 24 healthy male volunteers. After baseline assessment of lactate transport and endurance performance, subjects will be randomized to either a 3-week intervention arm in which they will train with glucose-fructose intake during training, or to a control arm (water during training). After this 3-week intervention, lactate transport and endurance performance will be assessed again.

Eligibility criteria: Inclusion Criteria:

* healthy
* age between 18 and 30 years
* sedentary
* BMI between 19 and 25
* blood pressure lower than 140/90 mmHg

Exclusion Criteria:

* smoking
* consumption of more than 10g alcohol per day
* cardiovascular history
* electrographic abnormalities at rest
* consumption of more than one can of soda per day or more than 60g sugars per day
* any current drug treatment
* consumption of drugs or illicit substances
* diabetes mellitus
* vegetarian
* food intolerance
* blood donation or participation to another study \<3 months before study inclusion

Primary outcomes:
measure: Change in lactate transport
timeFrame: At baseline (before training) and after the 3-week training protocol
Secondary outcomes:
measure: Change in muscle monocarboxylate transporters (MCTs) expression and protein content
timeFrame: At baseline (before training) and after the 3-week training protocol
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: University of Lausanne
state: Vaud
Study officials:
affiliation: University of Lausanne
name: Luc Tappy, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lecoultre V, Benoit R, Carrel G, Schutz Y, Millet GP, Tappy L, Schneiter P. Fructose and glucose co-ingestion during prolonged exercise increases lactate and glucose fluxes and oxidation compared with an equimolar intake of glucose. Am J Clin Nutr. 2010 Nov;92(5):1071-9. doi: 10.3945/ajcn.2010.29566. Epub 2010 Sep 8.
Clinical trial NCT00478686: Association of Dihydropyrimidine Dehydrogenase (DPYD) Variants With Toxicity Related to Capecitabine
Official title: A Retrospective Analysis of the Association of Dihydropyrimidine Dehydrogenase (DPYD) Variants With Toxicity Related to Capecitabine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast Cancer
Dihydropyrimidine Dehydrogenase
DPYD
DPYD Variants
Toxicity
Capecitabine
Xeloda
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Myrexis Inc.
First posted: 2007-05-25
Enrollment: 102
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with breast cancer who experienced toxicity/side effects related to capecitabine chemotherapy.

Brief summary: The goal of this laboratory research study is to identify possible differences in a gene among patients with breast cancer that cannot be treated by surgery. Researchers want to find out if differences in this gene may increase the risk of side effects from capecitabine.

Detailed description: If you agree to take part in this study, 1 blood sample (about 2 tablespoons) will be drawn for use in genetic research.

If you are unable to provide a blood sample, researchers will collect leftover tissue samples from your previously collected tumor tissue (from the time of the breast cancer diagnosis). The tumor samples will be used for genetic research.

After the blood draw or tissue collection, your participation in this study will be over.

The blood samples for the genetic research will be stored at Myriad Laboratories. Before your blood and/or tissue is sent to Myriad Laboratories for banking, your name and any personal identifying information will be coded to protect your privacy. M. D. Anderson will not have oversight of any leftover tissue and/or blood that will be banked by Myriad Laboratories for additional research.

This is an investigational study. Up to 210 patients will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility criteria: Inclusion Criteria:

1. Patients must be registered for protocol ID 01-580 and only patients who were randomized to receive capecitabine will be included in the study.
2. Patients must sign an informed consent for this protocol.

Exclusion Criteria:

1) There are no exclusion criteria.

Primary outcomes:
measure: Incidence of DPYD variants in patients
timeFrame: 2 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Vicente Valero, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02907086: Circulating Tumor Material in Colorectal Cancer and Melanoma
Official title: Protocol to Permit the Acquisition of Circulating Tumor Material in Colorectal Cancer and Melanoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer and Melanoma
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2016-09-20
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: colorectal cancer and melanoma patients

Brief summary: Observational study to allow the collection of blood and medical information to evaluate the role of circulating tumor material in patients with colorectal cancer and melanoma


Eligibility criteria: Inclusion Criteria:

* The subject must be a patient at the Hospital of the University of Pennsylvania

  1. Patients with presumed stage II, III, or IV colorectal cancer with planned surgical resection of either the primary tumor or metastatic lesion(s) being evaluated at the Hospital of the University of Pennsylvania
  2. Patients with histologically confirmed melanoma stage IIb, IIc, IIIa, IIIb, or IIIc/IV scheduled for surgical resection being evaluated at the Hospital of the University of Pennsylvania.
* The subject must be able to provide informed consent or have an acceptable surrogate capable of giving consent on the subject's behalf.
* The subject must be 18 years of age or older.

Exclusion Criteria:

* The subject is not able to provide informed consent.

Primary outcomes:
measure: Number of blood samples collected
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Mark O'Hara, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02643186: Vaginal Misoprostol Versus Bilateral Uterine Artery Ligation in Decreasing Blood Loss in Trans-abdominal Myomectomy
Official title: Vaginal Misoprostol Versus Bilateral Uterine Artery Ligation in Decreasing Blood Loss in Trans-abdominal Myomectomy , a Randomized Control Trail
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Vaginal Misoprostol and Bilateral Uterine Artery Ligation in Decreasing Blood Loss in Trans-abdominal Myomectomy
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2015-12-31
Enrollment: 62
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study aims at comparison between the effect of preoperative misoprostol and bilateral uterine artery ligation regarding their effect to decrease blood loss in transabdominal myomectomy.


Eligibility criteria: Inclusion Criteria:

* women in the reproductive age (20-40 years) diagnosed as having uterine fibroids who are consenting to have trans- abdominal myomectomy in the postmenstrual period diagnosed by: clinical symptoms and signs:
* abnormal uterine bleeding (menorrhagia or/and metrorrhagia)
* pain (dull aching lower abdominal pain or dysmenorrhea)
* pressure symptoms (dyspareunia, dysuria, dyschezia or /and backache)
* progressive abdominal enlargement (abdominal swelling) ultrasound (abdominal or transvaginal) to confirm the clinical diagnosis:
* maximum diameter of the largest fibroid is greater than 4 cm
* maximum number of uterine myomas is not to be more than 5 myomas
* uterine fibroid may be subserous or intramural

Exclusion Criteria:

* obesity (BMI \>30 kg/m2)
* cardiac, endocrine, pulmonary or hematological disease (including anemia; hemoglobin level below 10 gm/dl)
* patients known to be allergic to prostaglandin preparations
* patients who received preoperative hormonal therapy (GnRH analogue)
* patients presented by or with suspected malignant gynecological disease patients diagnosed as having submucous uterine fibroids, cervical or supracervical fibroids, broad ligamentary fibroids and pedunculated fibroids patients with contraindication to general anaesthesia
* patients with positive pregnancy test
* virgin patients

Primary outcomes:
measure: estimated intraoperative blood loss measured in milliliters
timeFrame: 60 min
Secondary outcomes:
measure: the need of intra-operative blood transfusion
timeFrame: 60 min
measure: the need for conversion from myomectomy to hysterectomy
timeFrame: 60 min
measure: operative time in minutes
timeFrame: 60 min
measure: intraoperative or postoperative complications
timeFrame: 24 hours
measure: differance between pre and post operative hemoglobin and hematocrit levels
timeFrame: 24 hours
measure: duration of hospital stay in days
timeFrame: 7 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
Clinical trial NCT00404586: Effects Of Single Doses Of GW784568X On Allergic Rhinitis Symptoms In Male Subjects Whilst In An Environmental Chamber
Official title: A Randomised, Placebo-controlled, 4-period, Incomplete Block, Crossover Study of 7 Days Dosing of Intranasal GW784568X (100mcg, 200mcg and 400mcg od), Fluticasone Propionate (200mcg od) and Placebo (Blinded for GW784568X vs Placebo) to Evaluate the Efficacy and Safety Using an Environmental Chamber in Male Subjects With Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rhinitis, Allergic, Perennial
Keywords: Environmental Challenge Chamber
GW784568X
Intranasal
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-11-29
Enrollment: 45
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study was designed to look at safety aspects and effects of intranasal doses of GW784568X on allergic rhinitis symptoms to develop this drug for its use in people who suffer with allergic rhinitis

Detailed description: A randomised, placebo-controlled, 4-period, incomplete block, crossover study of 7 days dosing of intranasal GW784568X (100mcg, 200mcg and 400mcg od), fluticasone propionate (200mcg od) and placebo (blinded for GW784568X vs placebo) to evaluate the efficacy and safety using an environmental chamber in male subjects with allergic rhinitis

Eligibility criteria: Inclusion criteria:

* Healthy with exception of seasonal rhinitis. May also have mild asthma.
* Weight greater than or equal to 50kg
* Non-smoker for at least 12 months

Exclusion criteria:

* History of frequent nosebleeds
* Have participated in another trial in the last 30 days.
* Have donated blood in the previous 3 months
* Have used prescription or non prescription drugs within last 7 days
* Have history of alcohol/drug abuse within last 12 months
* Have positive Hepatitis B or C test within 3 months of screening
* Subject tested positive for HIV

Primary outcomes:
measure: Nasal symptom scores after 7 days of dosing
timeFrame: after 7 days of dosing
Secondary outcomes:
measure: Nasal symptom scores Eye symptom scores Other symptom scores Nasal secretion and airflow on Day 7 and Day 8 after being exposed to allergen
timeFrame: on Day 7 and Day 8
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: