louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02723045: Quality of Life of TEP vs Lichtenstein Hernioplasty
Official title: The Comparison of the Quality of Life and Outcomes in Patient's With Reducible Inguinal Hernias: Laparoscopic Totally Extra-peritoneal (TEP) Versus Modified Lichtenstein Hernioplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inguinal Hernia
Lead sponsor: Sarawak General Hospital
Sponsor class: OTHER
First posted: 2016-03-30
Enrollment: 100
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: To determine if there is a difference in the quality of life in between patients who undergoes laparoscopic totally extra-peritoneal (TEP) or modified Lichtenstein hernioplasty

Detailed description: Patients presenting with reducible inguinal hernias will be randomized between open or laparoscopic repair groups. The primary outcome will be the quality of life scores. Patients will be followed-up for 12 months.

Eligibility criteria: Inclusion Criteria:

* 18 years of age and older
* Both genders
* Unilateral inguinal hernias
* Reducible inguinal hernias
* Elective setting

Exclusion Criteria

* ASA Physical Status (American Society of Anaesthesiologists) Grade \> 2
* Recurrence
* Inguinal-scrotal hernias
* Prostatectomy, Pfannenstiel incision, previous pre-peritoneal surgery
* Pregnancy
* Refusal for general anaesthesia

Primary outcomes:
measure: Quality of life
timeFrame: 12 months
Secondary outcomes:
measure: Operating time
timeFrame: 12 months
measure: Duration of hospitalization
timeFrame: 12 months
measure: Complications
timeFrame: 12 monthts
measure: Recurrence
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05300945: HIPEC Combined Gastrectomy in Patients With Advanced Gastric Cancer Received Neoadjuvant Chemotherapy
Official title: HIPEC Combined Gastrectomy in Patients With Advanced Gastric Cancer Received Neoadjuvant Chemotherapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Gastric Cancer
Peritoneal Metastases
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with stage cT3-4N+M0 gastric cancer were recommended to receive neoadjuvant chemotherapy before radical surgery in terms of the eradication of micrometastasis in addition to local control, higher compliance with intensive chemotherapy, and avoidance of futile surgery by detection of initially invisible distant metastasis after rapid disease progression. However, in some studies, gastrectomy followed by neoadjuvant chemotherapy failed to demonstrate survival benefits for these patients. And peritoneal recurrence was the most common and devastating reason. Hyperthermic intraperitoneal chemotherapy (HIPEC) was introduced for peritoneal cancer last century. A few studies suggested HIPEC could improve prognosis in patients with limited peritoneal metastasis from various cancer. In summary, we conducted this study to confirm the efficacy and safety of HIPEC after gastrectomy in patients with advanced gastric cancer received neoadjuvant chemotherapy.


Eligibility criteria: Inclusion Criteria:

* histologically proven adenocarcinoma of stomach
* stage cT3-4N+M0
* no involvement of esophagus \> 3 cm
* ECOG (Eastern Cooperative Oncology Group) : 0\~1
* no previous chemotherapy or radiotherapy for any malignancy
* no previous surgery for GC excluding endoscopic mucosal resection or endoscopic submucosal dissection
* Signed the Informed Consent Form

Exclusion Criteria:

* Serious diseases that are difficult to control
* Severe hepatic and renal dysfunction
* Abnormal coagulation
* The presence of other serious physical or mental illness or laboratory abnormalities may increase the risk of participating in the study, or interfere with the results of the study, as well as the patients who the investigator believes are not suitable for participating in the study

Primary outcomes:
measure: Peritoneal recurrence
timeFrame: 3 years
measure: OS
timeFrame: 3 years
Secondary outcomes:
measure: DFS
timeFrame: 3 years
measure: Adverse Events
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05458245: TIBOLA : Multicenter Descriptive Study in Eastern France
Official title: TIBOLA : Multicenter Descriptive Study in Eastern France
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: TIBOLA
Rickettsia Infections
Keywords: dermacentor
DEBONEL
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2022-07-14
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Definite case: clinically compatible (inoculation eschar with locoregional adenopathy(s) +/- general signs) +/- tick bite noted AND microbiological proof (positive PCR or seroconversion for a microorganism responsible for TIBOLA) OR
* Probable case: clinically compatible (inoculation eschar with locoregional adenopathy(s) +/- general signs) AND tick bite noted without microbiological proof.

Brief summary: TIBOLA (TIck-BOrne LymphAdenopathy) is a tick-borne disease. The pathogen is most often rickettsia (R. slovaca or R. raoultii), but other strict intracellular bacteria have been described (Francisella tularensis, Coxiella burnetii, Bartonella hensenlae).

Transmitted by ticks (Dermacentor), it is characterized by an inoculation eschar at the tick bite site, accompanied by painful loco-regional lymphadenopathy. It is most often a benign pathology, which can nevertheless leave sequellar alopecia or persistent asthenia.

In spring 2021, an impression of increased cases was reported by clinicians in Eastern France. The study aims to clarify the clinical-biological presentation and the evolution of the number of cases of TIBOLA in this region between 2016 and 2021.

At the same time, entomologists have noted an upsurge in this tick in certain biotopes in recent years.


Eligibility criteria: Inclusion Criteria:

* Person, minor or major,
* having been diagnosed with TIBOLA
* between January 1, 2016 and December 31, 2021
* at the University Hospital of Nancy or Strasbourg in the departments of infectious and tropical diseases, dermatology, microbiology and pediatrics.

Primary outcomes:
measure: Number of cases of TIBOLA
timeFrame: baseline
Secondary outcomes:
measure: Epidemiological and demographic characteristics
timeFrame: baseline
measure: Characteristics of tick bites
timeFrame: baseline
measure: Frequency of the various symptoms and clinical signs of the disease
timeFrame: baseline
measure: Biological results
timeFrame: baseline
measure: Treatment
timeFrame: baseline
measure: Entomological analysis
timeFrame: evolution between 2016 and 2021
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Yves Hansmann
city: Vandœuvre-lès-Nancy
country: France
facility: Elisabeth Baux
Study officials:
References:
Clinical trial NCT04177745: Hot and Cold Applications on PVC Insertion
Official title: The Effectiveness of Local Hot and Cold Applications on Peripheral Intravenous Catheters: A Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Venous Catheterization
Keywords: Peripheral venous catheter
hot application
cold application
pain
anxiety
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2019-11-26
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Background: This study was conducted to examine the effect of local hot and cold applications on pain, anxiety level, length of application, and vein evaluation prior to inserting PVC.

Methods: This randomised controlled trial was conducted with patients who were hospitalised in the cardiology department of a university hospital. PVC was inserted, the researcher applied a hot or cold application to the catheter insertion site for one minute.

Detailed description: Background: This study was conducted to examine the effect of local hot and cold applications on pain, anxiety level, length of application, and vein evaluation prior to inserting PVC.

Methods: This randomised controlled trial was conducted with patients who were hospitalised in the cardiology department of a university hospital. The sample was comprised of 90 individuals, including 30 in the cold application group, 30 in the hot application group, and 30 in the control group receiving treatment in the Cardiology Clinic between November and December 2018.

Eligibility criteria: Inclusion Criteria:

* being able to speak and understand Turkish,
* being over 18 years of age,
* having unimpaired sense of time or place orientation,
* having no psychiatric disorders,
* having no visual or hearing problem,
* having indication of IV catheter application,
* having no administration of analgesic or anaesthetic agents prior to IV catheter insertion,
* having catheter inserted in one attempt,
* having no allergy to hot and cold applications,
* being voluntary to participate in the study.

Exclusion Criteria:

* infection
* previous history of surgery,
* scarring in the catheter insertion site,
* psoriasis in the catheter insertion site,
* active dermatitis in the catheter insertion site,
* peripheral nerve disease,
* diabetes,
* peripheral neuropathy in the catheter insertion site

Primary outcomes:
measure: Numeric Rating Scale for pain and anxiety
timeFrame: Before catheter insertion
measure: Vein Assessment Scale
timeFrame: Before hot/cold application
Secondary outcomes:
measure: Numeric Rating Scale for pain and anxiety
timeFrame: During catheter insertion
measure: Vein Assessment Scale
timeFrame: Immediately before insertion of the catheter
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University
Study officials:
affiliation: TC Erciyes University
name: Sevda Korkut, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04979845: Telerehabilitation in Multiple Sclerosis
Official title: The Effect on Telerehabilitation on Fatigue and Sleep Quality in Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Patients with multiple sclerosis will be randomized into two groups. One group will receive live telerehabilitation sessions 3 times a week over a course of three months. The other group will receive video instructions for aerobic and strengthening exercises. Patients fatigue, sleep quality and quality of life will be measured.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of multiple scleroisis

Exclusion Criteria:

* Any musculoskeletal condition preventing patients to actively participate in exercise sessions

Primary outcomes:
measure: Pittsburgh Sleep Quality Scale
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
Study officials:
References:
Clinical trial NCT00362245: Amikacin Penetration Into the Cerebrospinal Fluid
Official title: Amikacin Penetration Into the Cerebrospinal Fluid: Pharmacokinetic/Pharmacodynamic Analysis in Adults With Hospital Acquired Gram-negative Meningitis Associated With Intracranial Pressure Monitoring and Draining Devices
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Gram Negative Meningitis
Post Traumatic Bacterial Meningitis
Keywords: Amikacin
Pharmacokinetics
Pharmacodynamics
Intra-Thecal injection
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2006-08-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The limited available data precludes establishing an antibiotic regimen in patients suffering from bacterial meningitis after head trauma, or spontaneous bleeding Understanding the disposition of Amikacin administered intrathecally will enable to propose rational treatment of these patients.

Detailed description: The limited available data precludes establishing an antibiotic regimen in patients suffering from bacterial meningitis after head trauma, or spontaneous bleeding Understanding the disposition of Amikacin administered intrathecally will enable to propose rational treatment of these patients.

Eligibility criteria: Inclusion Criteria:

1. Culture proved bacterial meningitis where the prescribed therapy includes the use of systemic and intraventricular amikacin therapy.
2. The included patient should have an intraventricular catheter placed for intraventricular pressure measurement and admitted to an intensive care unit.
3. Blood creatinine concentration up to 1.49 mg/dL measured at the inclusion day.

Exclusion Criteria:

1. Patients or legal guardians who refuse to participate in the study.
2. Known allergy to amikacin.
3. Blood creatinine concentration of 1.5 mg/dL or higher.
4. Subjects without intraventricular catheter who will need repeated lumbar punctures for CSF amikacin determinations.
5. Patients suffering from known chronic liver disease.

Primary outcomes:
measure: Bactericidal effect on the causative bacteria
measure: Blood and CSF AUC/MIC relationship
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
affiliation: Rambam Health Care Campus
name: Yedidiah Bentur, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01177345: Burden of Cervical Cancer in Tanzania
Official title: Survey Assessment and Projection of the Social and Economic Burdens of Cervical Cancer in Tanzania
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Cancer
-Socioeconomic Burden of Disease
Lead sponsor: Kilimanjaro Christian Medical Centre, Tanzania
Sponsor class: OTHER
First posted: 2010-08-09
Enrollment: 105
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women diagnosed with cervical cancer at the Reproductive Health Clinic at Kilimanjaro Christian Medical Centre (KCMC) and satellite cervical cancer screening clinics in rural areas affiliated with KCMC.

Brief summary: Cervical cancer screening is a worldwide problem especially in the developing world of which Tanzania belongs. It is diagnosed late in the third world because there are no diagnostic facilities and resource people. It occurs in the age groups between 40 and above and therefore affects the productive age of the community. It is well known that women generally are the backbone of every community and specifically in the developing countries.

The objective of this research is to analyze and quantify the burden of cervical cancer disease in the community. It will research the interpersonal and socioeconomic issues associated with cervical cancer disease in the family.


Eligibility criteria: Inclusion Criteria:

* new pathological diagnosis of cervical cancer

Exclusion Criteria:

* non consenting individuals

Primary outcomes:
measure: Socioeconomic burden to households
timeFrame: 12 months
Secondary outcomes:
measure: Projection of economic impact on community
timeFrame: 12 months
Other outcomes:
Locations:
city: Moshi
country: Tanzania
facility: Kilimanjaro Christian Medical Center
state: Kilimanjaro Region
Study officials:
References:
Clinical trial NCT01419145: A Feasibility Study of Multimodal Exercise/Nutrition/Anti-inflammatory Treatment for Cachexia - the Pre-MENAC Study
Official title: A Feasibility Study of Multimodal Exercise/Nutrition/Anti-inflammatory Treatment for Cachexia - the Pre-MENAC Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Cachexia
Keywords: cachexia
neoplasms
complications
combined modality therapy
exercise therapy
diet therapy
anti-inflammatory agents
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: University of Edinburgh
name: Oslo University Hospital
name: NHS Greater Glasgow and Clyde
name: Copenhagen University Hospital at Herlev
First posted: 2011-08-17
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A multicentre, open, randomized phase II study comparing a multimodal intervention (oral nutritional supplements, celecoxib and physical exercise) for cachexia versus standard cancer care.


Eligibility criteria: Main eligibility criteria:

* Advanced non-small-cell lung cancer (stage III-IV) or pancreatic cancer not eligible for curative therapy
* Due to commence chemo- or chemo radiotherapy
* Karnofsky Performance Score ≥ 70
* A life expectancy of ≥4 months and considered able to complete 2 months of the study

Primary outcomes:
measure: Feasibility of recruitment and retention
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital Ullevål
city: Trondheim
country: Norway
facility: St Olavs Hospital
city: Edinburgh
country: United Kingdom
facility: University of Edinburgh
Study officials:
affiliation: National Taiwan Normal University
name: Stein Kaasa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Edinburgh
name: Ken Fearon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Solheim TS, Laird BJA, Balstad TR, Stene GB, Bye A, Johns N, Pettersen CH, Fallon M, Fayers P, Fearon K, Kaasa S. A randomized phase II feasibility trial of a multimodal intervention for the management of cachexia in lung and pancreatic cancer. J Cachexia Sarcopenia Muscle. 2017 Oct;8(5):778-788. doi: 10.1002/jcsm.12201. Epub 2017 Jun 14.
citation: Balstad TR, Brunelli C, Pettersen CH, Schonberg SA, Skorpen F, Fallon M, Kaasa S, Bye A, Laird BJA, Stene GB, Solheim TS. Power Comparisons and Clinical Meaning of Outcome Measures in Assessing Treatment Effect in Cancer Cachexia: Secondary Analysis From a Randomized Pilot Multimodal Intervention Trial. Front Nutr. 2021 Jan 14;7:602775. doi: 10.3389/fnut.2020.602775. eCollection 2020.
citation: Stene GB, Balstad TR, Leer ASM, Bye A, Kaasa S, Fallon M, Laird B, Maddocks M, Solheim TS. Deterioration in Muscle Mass and Physical Function Differs According to Weight Loss History in Cancer Cachexia. Cancers (Basel). 2019 Dec 3;11(12):1925. doi: 10.3390/cancers11121925.
Clinical trial NCT06169345: The Long-term Course of Moderate Tricuspid Regurgitation
Official title: The Long-term Clinical Course of Moderate Tricuspid Regurgitation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tricuspid Regurgitation
Heart Failure
Echocardiography
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with an echocardiographic diagnosis of moderate tricuspid regurgitation at our center between 2010 and 2019

Brief summary: To evaluate the long-term clinical outcome of a cohort of patients suffering from moderate tricuspid regurgitation (TR), regardless of its etiology.


Eligibility criteria: Inclusion Criteria:

1. Patients with an echocardiographic diagnosis of moderate TR
2. Patients with echocardiographic and clinical follow-up information available at least 6-months after moderateTR diagnosis.

Exclusion Criteria:

1. Absence of an appropriate clinical and echocardiographic follow-up
2. A history of previous TV intervention (either surgical or percutaneous)
3. The presence of concomitant TV stenosis
4. Congenital heart disease
5. Left ventricular assist devices

Primary outcomes:
measure: All-cause death
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: Cardiovascular (CV) mortality
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Irccs San Raffaele
Study officials:
References:
Clinical trial NCT05514145: The Effectiveness of Combined Design Nance/Transpalatal Arch Appliance in Maintaining Arch Dimensions After Premature Extraction of Primary Molars
Official title: The Effectiveness of Combined Design Nance/Transpalatal Arch Appliance in Maintaining Arch Dimensions After Premature Extraction of Primary Molars (Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Space Maintenance
Keywords: Nance/transpalatal arch
Nance space maintainer
Space maintainer
Space maintenance
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-08-24
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized parallel controlled clinical trial
Primary purpose: PREVENTION

Brief summary: This study will evaluate the effectiveness of N-TPA appliance compared to Nance SM in maintaining the arch dimensions after bilateral premature extraction of primary molars in children.

Detailed description: In this randomized controlled clinical trial, 30 healthy children, 8-9 years of age with premature extraction of bilateral maxillary primary molars will be selected. Children will be randomly allocated into two equal groups of 15 children each according to the type of the appliance that will be used. Group I will receive a a Nance SM, and Group II a combined N-TPA appliance . Panoramic X-rays and study casts will be made, and baseline measurements will be recorded including arch circumference, intermolar width and arch depth. The appliances will be fabricated and cemented intra-orally.

The patients will be followed up at 3, 6 and 9 months for re-evaluation of arch circumference, intermolar width, arch depth, and patient acceptance.

Eligibility criteria: Inclusion Criteria:

* Fully erupted maxillary permanent first molars.
* Angle's class I occlusion.(31)
* Adequate space for premolar eruption according to Moyer's arch length analysis.(31)
* Fair to good oral hygiene according to Silness and Loe plaque index.(32)
* No history of allergy to polymethyl methacrylate.

Exclusion Criteria:

* Children with congenitally absent permanent successors.
* Children with successors not covered by bone with 2/3 of the root formed.(33)

Primary outcomes:
measure: Efficacy in maintaining arch dimensions
timeFrame: 9 months
Secondary outcomes:
measure: Patient acceptance by modified faces pain scale
timeFrame: 9 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of dentistry, Alexandria University
Study officials:
References: