louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01103570: Cholecyst- Versus Cystic Duct Cholangiography During Laparoscopic Cholecystectomy
Official title: Cholecystocholangiography Versus Cystic Duct Cholangiography During Laparoscopic Cholecystectomy: A Prospective Controlled Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Laparoscopic Cholecystectomy
Gall Stone Disease
Biliary Tract Anatomy
Common Bile Duct Stones.
Keywords: Laparoscopic cholecystectomy
Intra-operative cholangiography
Lead sponsor: Theodor Bilharz Research Institute
Sponsor class: OTHER
First posted: 2010-04-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Standard cystic duct cholangiography (CDC) during laparoscopic cholecystectomy can be difficult, time consuming and bile duct injury may be caused by attempts to cannulate the cystic duct. Operative cholangiography performed by direct puncture of the gall bladder fundus or Cholecystocholangiography (CCC) is a valid and easier alternative.

Detailed description: This study was conducted on 60 patients with symptomatic gall bladder stones undergoing laparoscopic cholecystectomy. Patients were randomized into two groups: Group (1) was evaluated by cholecyst-cholangiography by puncture through the gall bladder fundus. Group (2) was evaluated for the standard cystic duct cholangiography.Cholangiography was considered successful if it could be performed with complete delineation of the biliary tree with flow of the dye through the duodenum occurred. It is to be noted that inability to cannulate the cystic duct for example, is considered a failure.

Eligibility criteria: Inclusion Criteria:

* patients with symptomatic gall bladder stones.

Exclusion Criteria:

* unfit Patients and/or had previous surgery
* history of obstructive jaundice and acute attacks or previous ERCP were excluded

Primary outcomes:
measure: success rate
timeFrame: 6 months
Secondary outcomes:
measure: procedure-related complications
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Department of General Surgery * Theodore Bilharz Research Institute
Study officials:
References:
Clinical trial NCT01561170: Electromagnetic Field Therapy to Improve Healing of Chronically Venous Ulcer
Official title: The Effect of Electromagnetic Field Therapy to Improve Healing of Chronically Venous Ulcer in Lower Extremities
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Venous Hypertension With Ulcer and Inflammation
Venous Ulcer Pain
Keywords: Electromagnetic
Field therapy
Chronically venous ulcer
Venous insufficiens
Lead sponsor: Northern Orthopaedic Division, Denmark
Sponsor class: OTHER
First posted: 2012-03-22
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: Chronically venous ulcer in lower extremities is a permanent and disabling disease. Venous insufficience is the main cause of chronic ulcer. There is a high prevalence and frequency of the disease, primarily among elderly people. Recently, electromagnetic field therapy has been tested on various diseases in musculoskeletal system with a beneficial effect. In recent years, there has been an increasing interest in using electromagnetic field therapy to treat chronically venous ulcer.

The hypothesis of the investigators is that the electronic magnetic field therapy improves the healing process and reduces pain for patients suffering from chronically venous ulcer. The investigators assume that the bioactivity is affected by a cellular response which affects the DNA synthesis, transcription og protein synthesis.


Eligibility criteria: Inclusion Criteria:

* Patients who suffer from ulcer in lower extremities
* Patients who suffer from venous insufficience detected by duplex scanning or by a pressure on digits \> 40 mmHg
* Patients with a regular need of compression stockings
* Age \> 18 years

Exclusion Criteria:

* Age \< 18 years
* Unability to read or understand Danish
* Patients who suffer from manifest neoplastic disorder

Primary outcomes:
measure: Reduction of ulcerous area.
timeFrame: 3 months
Secondary outcomes:
measure: Pain reduction in proportion to Visual Analogue Scale (VAS).
timeFrame: 3 months
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Northern Orthopaedic Division, Aalborg University Hospital,
Study officials:
affiliation: Northern Orthopaedic Department, Aalborg University Hospital, Denmark
name: Vesal Khalid, M.D.
role: STUDY_CHAIR
affiliation: Cardiology Department, Aalborg University Hospital, Denmark
name: Nils Johannesen, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT06030570: Effect of an Interdisciplinary Spine Rehabilitation Program
Official title: PROGRESS: The Effect of an Interdisciplinary Program for Rehabilitation for Spinal Disorders
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Low Back Pain
Spine Disease
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 90
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 with chronic spine problems in which a multidisciplinary approach is needed

Brief summary: The goal of this research project is to evaluate the effectiveness of the current interdisciplinary rehabilitation program (Revita) and follow-up trajectory for chronic lumbar spine disorders in the University Hospitals Leuven.


Eligibility criteria: Inclusion criteria

* Adults, age \> 18 years
* Spine problem for \> 6 weeks, needing interdisciplinary care (risk factors, failure of first line treatment, etc)
* Inclusion in Revita program
* Informed consent to participate

Exclusion criteria

* Patients without sufficient understanding of the Dutch language
* Unable to participate in 2h rehabilitation sessions with exercises

Primary outcomes:
measure: Change in Oswestry Disability Index (ODI)
timeFrame: baseline - 6 months - 1 year
measure: Change in pain
timeFrame: baseline - 6 months - 1 year
Secondary outcomes:
measure: Effect on quality of life
timeFrame: baseline - 6 months - 1 year
measure: Effect on risk stratification tool
timeFrame: baseline - 6 months - 1 year
measure: Effect on anxiety and depression
timeFrame: baseline - 6 months - 1 year
measure: Effect on kinesiophobia
timeFrame: baseline - 6 months - 1 year
measure: Effect on fear-avoidance beliefs
timeFrame: baseline - 6 months - 1 year
measure: Effect on body awareness
timeFrame: baseline - 6 months - 1 year
measure: Treatment experience
timeFrame: 6 months - 1 year
measure: Return to Work self-efficacy
timeFrame: baseline - 6 months - 1 year
measure: Return to work
timeFrame: baseline - 6 months - 1 year
measure: Effect on functioning
timeFrame: baseline - 6 months - 1 year
measure: Effect on medication use
timeFrame: baseline - 6 months - 1 year
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
References:
Clinical trial NCT05949970: The Lumbar Trident Study
Official title: Lumbar Facet Joint Denervation with a Trident Electrode, a Retrospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Facet Joint Pain
Lead sponsor: Ospedale Regionale di Lugano
Sponsor class: OTHER
First posted: 2023-07-18
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adult patients that are treated with radiofrequency (RF) ablation of the facet joints in patients selected by symptom improvement with dual medial branch blocks.

Brief summary: This observational retrospective study evaluates the efficacy of RF with the three-tined expandable electrode needle compared to before treatment in the treatment of chronic lumbar facet joint pain.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years old
* Patients with lumbar pain
* Patient who had two diagnostic medial branch blocks with significant (\>50%) improvement on both injections

Exclusion Criteria:

- No patient related outcome measures available in hospital's patient charts

Primary outcomes:
measure: Pain measurement by numeric rating score
timeFrame: 2 months after injection in comparison to baseline
Secondary outcomes:
measure: Patient Global Impression of Change (PGIC)
timeFrame: 2 months after injection
measure: Use of analgesics
timeFrame: 2 months after injection
measure: Sleep
timeFrame: 2 months after injection
measure: Walking ability
timeFrame: 2 months after injection
measure: Patient satisfaction
timeFrame: 2 months after injection
Other outcomes:
Locations:
city: Lugano
country: Switzerland
facility: Pain Management Center, Neurocenter of Southern Switzerland
Study officials:
affiliation: Neurocenter of Southern Switzerland, EOC, Lugano
name: Eva Koetsier, MD PhD LLM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06250270: Effects of Casein Protein on Metabolism When Taken Prior to Sleep and in the Morning
Official title: Effects of Casein Protein on Metabolism When Taken Prior to Sleep and in the Morning
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Metabolism
Keywords: Metabolism
Lead sponsor: Ohio University
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effect of casein protein consumption both prior to sleep as well first thing in the morning on metabolism (increase satiety and appetite, lower resting metabolic rate, and lower blood sugar levels), when compared to nighttime protein or placebo consumption alone. Protein itself is a macronutrient that not only helps the body repair itself, and play a critical role in growth, it also aids in increasing satiety and decreasing appetite. Casein protein specifically is slow digesting dairy protein which may impact the body's metabolism for a longer period than other dairy proteins such as whey. The literature demonstrates nighttime protein ingestion prior to sleep increases metabolic rate and satiety the next morning. However, there appears to be no data on the metabolic effects of protein ingested both at night and in the morning.


Eligibility criteria: Inclusion Criteria:

* male
* aged 18-30

Exclusion Criteria:

* lactose intolerant
* having known sleep issues
* being on a schedule that is not uniform week to week
* those who do not eat animal-based diets
* any known or suspected food allergies
* any known health conditions (cardiovascular disease, IBS, high blood pressure, diabetes, crohn's disease)
* those that have disordered eating
* unwillingness to take blood sugar four times a day
* being a female

Primary outcomes:
measure: resting metabolic rate
timeFrame: baseline, during the intervention
measure: blood glucose
timeFrame: baseline, during the intervention
Secondary outcomes:
measure: dietary intake
timeFrame: during the intervention
Other outcomes:
Locations:
city: Athens
country: United States
facility: Ohio University Exercise Physiology Lab
state: Ohio
Study officials:
References:
Clinical trial NCT04555642: Early Diagnosis of Therapy-associated Cardiotoxicity Basing on Multi-tracer Multimodality PET/MRI
Official title: Early Diagnosis of Therapy-associated Cardiotoxicity Basing on Multi-tracer Multimodality PET/MRI
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Positron-Emission Tomography
Magnetic Resonance Imaging
Keywords: Positron-Emission Tomography
cardiotoxicity
Magnetic Resonance Imaging
FDG
FAPI
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2020-09-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with malignant tumor after chemotherapy or immunotherapy

Brief summary: Using Multi-tracer to early diagnosis of therapy-associated cardiotoxicity using multimodality PET/MRI.

Detailed description: In this study investigators evaluated cardiac uptake by different molecular probe such as FDG, FAPI-04 using multimodality PET/MRI. Previous studies have shown that increased cardiac uptake of FDG on PET may be an indicator of myocardial injury after chemotherapy. Cardiac magnetic resonance (CMR) allows for multiparametric evaluation of cardiac morphology, ventricular function, myocardial perfusion, and viability. The combination of PET with MR (PET/MR) is therefore an alternative attractive pairing for diagnostic imaging. The aim of this study is to find noninvasive and effective method for early diagnosis of cardiotoxicity after chemotherapy or immunotherapy

Eligibility criteria: Inclusion Criteria:

* availability of a clinical pre- and post-therapy clinical evaluation encompassing electrocardiogram (ECG) ;
* normal findings at pre-therapy clinical evaluation;
* cancer planned chemotherapy or immunotherapy scheme ;
* available staging FDG-PET/CT scan (PET0);

Exclusion Criteria:

* cannot lie supine for half an hour;
* refuse to join the clinical researcher;
* without metal implants.

Primary outcomes:
measure: SUVR
timeFrame: 150 days
Secondary outcomes:
measure: Change Of Mapping Value and LVEF From Baseline
timeFrame: 150 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital
state: Beijing
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Zhi Yang, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00018642: Quetiapine vs Haloperidol Decanoate for the Long Term Treatment of Schizophrenia and Schizoaffective Disorder
Official title: Predicting the Optimal Pharmacotherapy for Outpatients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: quetiapine
haloperidol decanoate
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-07-05
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 purpose of this research study is to determine whether a new drug for schizophrenia is better for the maintenance treatment than a standard drugs currently prescribed. The new medication is called quetiapine and it will be compared with a standard medication called haloperidol decanoate. The study will determine if quetiapine causes fewer problems than haloperidol with side effects such as stiffness and restlessness and whether it costs the VA more or less to treat patients with quetiapine. In addition, blood samples will be collected every three months to determine if certain chemicals in the blood can influence the outcome of the subjects' illness.


Eligibility criteria: Inclusion Criteria

1. Schizophrenia or Schizoaffective Disorder diagnosed by DSM-IV
2. Between the ages 18-60.
3. A candidate for maintenance antipsychotic therapy. This means that patients will have had at least two documented episodes of acute schizophrenic illness or at least two years of continuing psychotic symptoms.

Exclusion Criteria

1. Organic brain disease.
2. Mental Retardation
3. Chronic medical illness which would make antipsychotic medication inappropriate.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System
state: California
Study officials:
References:
Clinical trial NCT00932542: Eutectic Mixture for Hemorrhoidectomy Postoperative
Official title: "Topic Effects of Eutectic Mixture Use in Local Anesthetics on Hemorrhoidectomy Postoperative (Prospective Study, Randomized, Triple Blind, Placebo-controlled)"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Hemorrhoidectomy
Keywords: Hemorrhoidectomy
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Cristália Produtos Químicos Farmacêuticos Ltda.
First posted: 2009-07-03
Enrollment: 144
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: Assess the efficacy and safety of the topic use of an eutectic mixture of local anesthetics for postoperative pain control of patients submitted to hemorrhoidectomy. Patients will be operated and discharged at the same day in a day hospital clinic. During the fourteen days recovery period, they will apply the study medication to the anal region 4 times daily. The Visual Analog Pain Scale (VAS) will be answered twice daily. Patients will also take 100 mg oral nimesulide twice daily and 50 mg tramadol on demand up to 4 times daily. The tramadol demand will be tabulated. A rescue medication for analgesia will be provided (sodium diclofenac IM).


Eligibility criteria: Inclusion criteria: male and female patients, older than 18, having internal hemorrhoid disease grade III or IV with indication of elective surgery, anesthetic risk ASA 1 or 2; able to read and write.

Exclusion criteria: allergy or hypersensitivity to the mixture components, perianal fistulas, fissures, ulcers, infectious and inflammatory processes or tumors to the anal region, chronic diarrhea, megacolon or colonic anatomical deformities, hemorrhoidal thrombosis, gangrene or any condition that changes the indication from elective to urgent, previous surgery to anal-rectal region, history or clinical signs of diabetes mellitis type I or II, pregnancy, intense anxiety or important emotional disorder, participation in any clinical trial within the 3 months preceding the inclusion, investigator´s opinion.

Primary outcomes:
measure: Reduction of pain evaluated by the analgesics demand.
timeFrame: Follow-up termination (1 month)
Secondary outcomes:
measure: Pain reduction by VAS
timeFrame: Follow-up termination (1 month)
measure: Tolerability by the adverse events incidence
timeFrame: Follow-up termination (1 month)
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Clínica Reis Neto
state: São Paulo
Study officials:
References:
Clinical trial NCT02023242: Comparing Effectiveness of the Hydrus Microstent (TM) to Two iStents to Lower IOP in Phakic Eyes
Official title: A Prospective, Multicenter, Randomized Comparison of the Hydrus to the iStent® for Lowering Intraocular Pressure in Primary Open Angle Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Open Angle Glaucoma
Pseudoexfoliative Glaucoma
Pigmentary Glaucoma
Keywords: Primary open angle glaucoma
POAG
Pseudoexfoliative glaucoma
PXG
Pigmentary glaucoma
PG
Hydrus
Lead sponsor: Ivantis, Inc.
Sponsor class: INDUSTRY
First posted: 2013-12-30
Enrollment: 152
Sex: ALL
Minimum age (years): 45
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial compares two implantable devices intended to lower the pressure inside the eye of glaucoma patients.

Detailed description: This is a prospective, multicenter, single-masked, randomized clinical trial comparing the Hydrus Microstent to two iStent implants for the reduction of intraocular pressure in phakic patients with a positive diagnosis of primary open angle glaucoma, pseudoexfoliative glaucoma, or pigmentary dispersion glaucoma. Post-operative follow-up visits will be conducted at regular intervals.

Eligibility criteria: Inclusion Criteria:

* A diagnosis of primary open angle glaucoma (POAG), Pseudoexfoliative (PXG) glaucoma, or Pigmentary glaucoma (PG)
* A phakic lens with BCVA of 20/30 or better

Exclusion Criteria:

* Forms of primary or secondary glaucoma not listed above
* Prior glaucoma surgery in the study eye

Primary outcomes:
measure: Unmedicated IOP </= 19 mmHg at 12 Months
timeFrame: 12 months
Secondary outcomes:
measure: The Percentage of Subjects Who Are Not Using Ocular Hypotensive Medications at 12 and 24 Months
timeFrame: 12 & 24 Months
measure: Mean Medication Use at 12 and 24 Months
timeFrame: 12 & 24 Months
measure: Unmedicated IOP </= 19 mmHg at 24 Months
timeFrame: 24 Months
measure: Unmedicated IOP </= 18 mmHg at 12 Months
timeFrame: 12 months
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Contact Richard Hope at Ivantis
state: California
Study officials:
affiliation: Madrid, Spain
name: Julian Garcia Feijoo, Prof. Med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01330342: Evolution of Cellular and Viral Resistance in HIV-infected Patients With Lymphoma
Official title: Evolution of Cellular and Viral Resistance in HIV-infected Patients With Lymphoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV
Lymphoma
Lead sponsor: St Stephens Aids Trust
Sponsor class: OTHER
First posted: 2011-04-06
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Sampling method: PROBABILITY_SAMPLE
Study population: HIV seropositive individuals with and without lymphoma.

Brief summary: The study's chief objective is to observe the evolution of cellular (in terms of expression of transmembrane transporters and their transcriptional regulators) and viral resistance (in terms of development of mutations in the HIV genome that may confer resistance to future treatment for HIV) in HIV-infected patients with lymphoma.

Detailed description: The study team will take two or three tubes of blood on three occasions during the course of chemotherapy. The total amount of blood required for this research project is 64mL (approximately 4 tablespoons).

This will allow better understanding of the changes that take place in the blood and the HIV virus itself. It is hoped that this will provide new insights that may aid the understanding and treatment of HIV patients with lymphoma.

Eligibility criteria: Inclusion Criteria:

* The ability to understand and sign a written informed consent form, prior to participation in any screening procedure and must be willing to comply with all study requirements.
* Documented HIV-1 infection.
* Diagnosis of lymphoma (with the exclusion of the five subjects that will be controls).
* On cART or about to start cART as part of clinical routine care before the initiation of chemotherapy.

Exclusion Criteria:

- Receiving anti-tuberculosis treatment.

Primary outcomes:
measure: Development of multi-drug resistance (in terms of expression of transmembrane transporters and their transcriptional regulators) in HIV-infected patients with lymphoma.
timeFrame: 3 years
Secondary outcomes:
measure: Development of mutations in the HIV genome that may confer resistance to future treatment for HIV.
timeFrame: 3 years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Stephen's Centre
Study officials:
affiliation: St Stephen's AIDS Trust
name: Marta Boffito, Dr
role: PRINCIPAL_INVESTIGATOR
References: