louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03763552: Arthroscopic Midcarpal Wrist Arthrodesis: Clinical and Functional Outcomes
Official title: Arthroscopic Midcarpal Wrist Arthrodesis: Clinical and Functional Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dislocation of Midcarpal Joint
Keywords: arthroscopy
wrist osteoarthrosis
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2018-12-04
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All cases of arthroscopic mid-carpal wrist arthrodesis for mid-carpal arthritis, related to post-traumatic or degenerative carpal deformity, performed in our Division from January 2015 to October 2017 will be studied. The approximate number of participants will be 15. There will be no control group.

Brief summary: All cases of midcarpal wrist arthritis treated surgically with arthroscopic partial wrist fusion with cannulated screws from January 2015 to December 2017 will be reviewed.

The union rate and time to union will be recorded following the standard radiological postoperative control. Wrist assessments performed pre- and postoperative regarding strength, range of motion and pain will be analysed. Complications will be recorded as well.

Participants will be recruited for wrist assessment. They will be asked to fill out questionnaires about the functional result related to their quality of life.


Eligibility criteria: Inclusion Criteria:

1. All the patients suffered from traumatic or degenerative mid-carpal wrist arthritis or instability and treated surgically with arthroscopic midcarpal wrist arthrodesis in the Division of Plastic Surgery and Hand Surgery University Hospital Zürich from January 2015 to October 2017 will be included.
2. Signed informed consent for participation in the study and for further use of collected data.

Exclusion Criteria:

1. Missing Informed consent

Primary outcomes:
measure: Wrist range of motion after surgery
timeFrame: 5 minutes
Secondary outcomes:
measure: Hand strength after surgery
timeFrame: 2 minutes
measure: Pain assessment in weight bearing (Visual analogue scale, VAS)
timeFrame: 1 minute
measure: Function assessment through DASH (The disabilities of the arm, shoulder, hand) questionnaire
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Olga Politikou
state: Schweiz
Study officials:
References:
citation: del Pinal F, Tandioy-Delgado F. (Dry) arthroscopic partial wrist arthrodesis: tips and tricks. Handchir Mikrochir Plast Chir. 2014 Oct;46(5):300-6. doi: 10.1055/s-0034-1387707. Epub 2014 Oct 7.
citation: del Pinal F, Klausmeyer M, Thams C, Moraleda E, Galindo C. Early experience with (dry) arthroscopic 4-corner arthrodesis: from a 4-hour operation to a tourniquet time. J Hand Surg Am. 2012 Nov;37(11):2389-99. doi: 10.1016/j.jhsa.2012.08.026.
Clinical trial NCT03112252: App Based Study on the Symptoms of Patients With Allergic Rhinitis in the Pollen Season
Official title: App-basierte Patientenbefragung Von Allergiepatienten Unter Medikation in Der Pollenflug-Saison Zur Bestimmung Der Auswirkung Einer Allergischen Rhinitis Auf Die Lebensqualität
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergic Rhinitis
Keywords: Immunotherapy
Lead sponsor: University Hospital of Cologne
Sponsor class: OTHER
First posted: 2017-04-13
Enrollment: 173
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with allergic rhinitis

Brief summary: App-based study of allergy patients under medication in the pollen season to determine the effect of allergic rhinitis on the quality of life.

Detailed description: The project aims to determine the effects of rhinitis on everyday life and thereby identify the affected pathways, irrespective of age, gender or gender socioeconomic status to lead a healthy and active life.

Eligibility criteria: inclusion criteria patients with allergic rhinitis

exclusion criteria none

Primary outcomes:
measure: allergic symptoms of patients
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Institute of Medical Statistics, Informatics and Epidemiology
state: NRW
Study officials:
affiliation: University Hospital of Cologne
name: Ralph Mösges, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06644352: Right Versus Left Thoracic Surgical Approaches for Siewert II Gastroesophageal Junction Adenocarcinoma
Official title: A Prospective, Randomized, Controlled, Multicenter Study Comparing the Right Versus Left Thoracic Surgical Approaches for Locally Advanced Siewert II Gastroesophageal Junction Adenocarcinoma After Neoadjuvant Chemotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Siewert Type II Adenocarcinoma of Esophagogastric Junction
Keywords: GastroEsophageal Cancer
Surgical Incision
Left thoracic incision
Right thoracic incision
Neoadjuvant chemotherapy
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 236
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: TREATMENT

Brief summary: To explore the 5-year overall survival (OS) of right versus left thoracic surgical approaches for patients with locally advanced Siewert II gastroesophageal junction adenocarcinoma treated by neoadjuvant chemotherapy


Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed gastroesophageal adenocarcinoma;
2. R0 resectable Siewert Ⅱ, cT2-3N0-3M0 (AJCC V8 TNM classification);
3. Have a performance status of 0 or 1 on the ECOG Performance Scale;
4. Age 18-80 years old, both men and women;
5. Estimated survival ≥6 months;
6. Be willing and able to provide written informed consent/assent for the trial;
7. Demonstrate adequate organ function ;
8. Female subject of childbearing potential should have a negative urine or serum pregnancy within 7 days before enrollment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required;
9. Have not received systemic or local treatment for esophageal cancer in the past.

Exclusion Criteria:

1. Have a history of other malignant tumors in the past or at the same time;
2. Previous upper abdominal surgery (excluding cholecystectomy);
3. Bleeding, perforation and obstruction requiring emergency surgical treatment;
4. Severe heart, lung, liver and kidney dysfunction, which the researcher thinks is not suitable for operation;
5. Hydrothorax and ascites with clinical symptoms need therapeutic puncture or drainage;
6. Participate in other clinical studies or less than 1 month from the end of the previous clinical study;
7. Have a history of psychoactive drug abuse, alcoholism or drug abuse;
8. Be unable or do not agree to bear the inspection and treatment expenses at their own expense;
9. The researcher thinks that it should be excluded from this study.

Primary outcomes:
measure: OS rate
timeFrame: 5 years
Secondary outcomes:
measure: DFS rate
timeFrame: 3 years
measure: pCR rate
timeFrame: 1 month after resection
measure: MPR rate
timeFrame: 1 month after resection
measure: Operative Complications
timeFrame: perioperative period
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
Study officials:
References:
Clinical trial NCT00435552: Ease-it Spray for the Treatment of Fire Ant Stings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Insect Bites and Stings
Lead sponsor: C.R.Darnall Army Medical Center
Sponsor class: FED
First posted: 2007-02-15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The application of Ease-it Spray will alleviate pain secondary to fire ant stings more quickly than placebo.


Eligibility criteria: Inclusion Criteria:

* AD soldier in US Army
* Ages 18-60
* Volunteer
* Absence of serious medical condition
* Past allergic reactions
* Asthma
* History of (h/o) IFA sting

Exclusion Criteria:

* Inability to provide informed consent
* Known h/o hymenoptera allergic reaction
* Allergy to any component of the treatments
* Inability to follow-up
* Active medical condition
* Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03694652: Texting for Mobility in Overweight/Obese Adults With Peripheral Artery Disease
Official title: Text Messaging to Promote Mobility in Overweight/Obese Adults With Peripheral Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: Text messaging
PAD
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-10-03
Enrollment: 29
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: By doing this study, researchers hope to learn about the feasibility of using a mobile application to help overweight or obese adults with PAD increase their walking distance and lose weight.

Detailed description: Peripheral artery disease (PAD) or poor leg circulation affects 8 to 12 million Americans including non-Hispanic Whites, African Americans and Latinos. Having PAD can limit how far you can walk. Many patients with PAD are also overweight or obese. Weight loss among overweight or obese adults with PAD may improve walking distance. Given how common obesity or being overweight is among persons with PAD, interventions are needed to address weight loss in this population.

Eligibility criteria: Inclusion Criteria:

* Overweight or obese (body mass index \>=27 kg/m2)
* Have symptomatic PAD
* English speaking
* Have 24 hour access to a cell phone

Exclusion Criteria:

* Cannot tolerate fruits and vegetables, fiber, and/or a low fat diet, as informed by a physician and/or registered dietician
* Restricted intake of water
* Pregnancy
* Prior major amputation (foot or lower leg) or critical leg ischemia (tissue loss, gangrene, or ulcers)
* Use of supplemental oxygen
* Heart attack within preceding 3 months

Primary outcomes:
measure: Walking Distance
timeFrame: Month 3
Secondary outcomes:
measure: Weight Loss
timeFrame: Month 3
measure: Quality of Life (QoL)
timeFrame: Month 3
measure: Physical Activity
timeFrame: Month 3
measure: Dietary Habits
timeFrame: Month 3
Other outcomes:
Locations:
city: Wichita
country: United States
facility: University of Kansas School of Medicine
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Tracie C Collins, MD, MPH, MHCDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Collins T, Geana M, Overton K, Benton M, Lu L, Khan F, Rohleder M, Ahluwalia J, Resnicow K, Zhu Y. Use of a Smartphone App Versus Motivational Interviewing to Increase Walking Distance and Weight Loss in Overweight/Obese Adults With Peripheral Artery Disease: Pilot Randomized Trial. JMIR Form Res. 2022 Feb 3;6(2):e30295. doi: 10.2196/30295.
Clinical trial NCT00187252: Mascot Study: Management of Atrial Fibrillation (AF) Suppression in AF-Heart Failure (HF) COmorbidity Therapy
Official title: Management of Atrial Fibrillation Suppression in AF-HF COmorbidity Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Atrial Fibrillation
Ventricular Dysfunction
Keywords: Ventricular Dyssynchrony
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 380
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: The purpose of this study is to evaluate whether adding AF Suppression™ to cardiac resynchronization therapy (CRT) improves the prognosis of heart failure patients benefiting from cardiac resynchronization therapy.


Eligibility criteria: Inclusion Criteria:

* HF patients
* New York Heart Association (NYHA) III - IV
* Spontaneous QRS ≥130 ms and/or mechanical interventricular delay \> 50 ms
* Left ventricular ejection fraction (LVEF) ≤ 35%
* Left ventricular end diastolic diameter (LVEDD) ≥ 55 mm
* Optimized medical regimen
* Age \> 18 years

Exclusion Criteria:

* Unstable angina or acute myocardial infarction (MI) (\< 3 months)
* Coronary artery bypass grafting (CABG) or percutaneous transluminal coronary angioplasty (PTCA) \< 3 months
* Life expectancy \< 6 months

  * Permanent AF
  * Pregnancy

Primary outcomes:
measure: Prevalence of permanent atrial fibrillation
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Firenze
country: Italy
facility: Clinica Medica Generale e Cardiologia - Ospedale Careggi
Study officials:
affiliation: Ospedale Carregi, Firenze, Italy
name: Luigi Padeletti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Padeletti L, Musilli N, Porciani MC, Colella A, Di Biase L, Ricciardi G, Pieragnoli P, Michelucci A, Gensini G. Atrial fibrillation and cardiac resynchronization therapy: the MASCOT study. Europace. 2004 Sep;5 Suppl 1:S49-54. doi: 10.1016/j.eupc.2004.07.007.
citation: Padeletti L, Muto C, Maounis T, Schuchert A, Bongiorni MG, Frank R, Vesterlund T, Brachmann J, Vicentini A, Jauvert G, Tadeo G, Gras D, Lisi F, Dello Russo A, Rey JL, Boulogne E, Ricciardi G; Management of Atrial fibrillation Suppression in AF-HF COmorbidity Therapy Study Group. Atrial fibrillation in recipients of cardiac resynchronization therapy device: 1-year results of the randomized MASCOT trial. Am Heart J. 2008 Sep;156(3):520-6. doi: 10.1016/j.ahj.2008.04.013. Epub 2008 Jul 7.
Clinical trial NCT01592552: A Biospecimen and Clinical Data Study on Patients for Drug & Biomarker Discovery
Official title: A Multi-Center Longitudinal Biorepository Study to Provide Biospecimens & Clinical Data From Neurological Disease Patients To Approved Pre-Clinical And Clinical Investigators for Drug & Biomarker Studies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer's Disease
Multiple Sclerosis
Parkinson's Disease
Huntington's Disease
Amyotrophic Lateral Sclerosis (ALS)
Keywords: Alzheimer's Disease
Multiple Sclerosis
Parkinson's Disease
Huntington's Disease
Amyotrophic Lateral Sclerosis (ALS)
Lead sponsor: Sanguine Biosciences
Sponsor class: INDUSTRY
First posted: 2012-05-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A diagnosis of Multiple Sclerosis, Alzheimer's, Huntington's, or Parkinson's Disease.

Brief summary: The purpose of this research project is to collect and store blood samples and clinical data. Researchers can then use the stored samples in future studies. Through such studies, they hope to find new ways to detect, treat, and maybe even prevent or cure health problems.

Detailed description: Blood samples are collected in the comfort and safety of your home by a certified medical professional. We have mobile phlebotomists located in major metropolitan areas around the nation for your convenience.

Eligibility criteria: Inclusion Criteria:

* Males and females \>18 to 100 years old
* A diagnosis of neurological condition
* Proof of diagnosis can be provided

Control group: Healthy donors, males and females, 18 to 100 years of age

Exclusion Criteria

* Receipt of blood products within 30 days of study enrollment
* Receipt of an investigational (unapproved) drug within 30 days of study enrollment

Primary outcomes:
measure: Biospecimens & Clinical Data collection from patients with neurological diseases.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sherman Oaks
country: United States
facility: Sanguine Biosciences
state: California
Study officials:
affiliation: Sanguine Biosciences
name: Phil Silkoff, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03290352: Pretreatment Quality of Life as a Predictor of Distant Metastasis-Free Survival and Overall Survival in Patients With Head and Neck Cancer
Official title: Pretreatment Quality of Life as a Predictor of Distant Metastasis-Free Survival and Overall Survival in Patients With Head and Neck Cancer Who Underwent Free Flap Reconstruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oncology
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2017-09-21
Enrollment: 127
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Head and neck cancer patients undergoing free-flap reconstruction

Brief summary: This study shed light on an under-researched area by examining the prognostic associations of pre-treatment QoL with overall survival and distant metastasis free survival among patients with head and neck cancer who underwent free flap reconstruction. In addition, a validated instrument specific to head and neck cancer, i.e. the University of Washington Quality of Life Questionnaire (UW-QoL) was adopted.

Detailed description: The importance of patient-related outcomes, especially quality of life (QoL) has been recently emphasized in the field of oncology. In conjunction with traditional biomedical indicators, QoL is recognized as a reliable parameter to reflect the health status of patients with malignancy. A growing body of evidence even points out that QoL can produce prognostic information which goes beyond biomedical indicators. In particular, since QoL may decline before any possible deterioration in health can be detected by existing biomedical measures, assessing pre-treatment QoL possibly helps identify the patients who are susceptible to a higher risk of mortality after they receive cancer treatment, which may greatly facilitate the process of clinical decision making. Despite the importance of pre-treatment QoL, its prognostic associations with overall survival and distant metastasis free survival still remain relatively under-explored.

Eligibility criteria: Inclusion Criteria:

* Patients with oral cavity, tongue, gingival, pharyngeal, laryngeal, or salivary gland cancer and cervical lymph node metastasis, and
* Received free flap reconstruction between November 2010 and June 2014 at a medical university hospital

Exclusion Criteria:

* Patients with distant metastasis identified in their medical records, or
* Undergoing reconstruction other than anterolateral thigh, fibular bone and radial forearm flaps

Primary outcomes:
measure: Overall survival of head and neck cancer patients with free-flap reconstruction
timeFrame: 3 years 8 months
Secondary outcomes:
measure: Distant metastasis free survival of head and neck cancer patients with free-flap reconstruction
timeFrame: 3 years 8 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05739552: Telerehabilitation in the Post-COVID-19 Patient (TRIALS)
Official title: Telerehabilitation in the Post-COVID-19 Patient: the Italy-Switzerland Experience
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-COVID-19 Syndrome
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
Collaborators: name: Politecnico di Milano
First posted: 2023-02-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A major issue brought about by the current pandemic concerns the discontinuation of a large proportion of outpatient services provided locally, especially in the rehabilitation field. Added to this situation is the ever-increasing demand for rehabilitation for post-COronaVIrus Disease 19 (COVID-19) patients. Data show that respiratory and motor rehabilitation for people infected with COVID-19 is necessary at all stages of the disease, even in the medium to long term after discharge from acute hospital care. Also to be taken into account are the logistical difficulties imposed by restrictions on the movement of individuals within the territory for both patients and caregivers, which are amplified in remote or poorly served areas, such as many cross-border territories. In this context, telerehabilitation can provide solutions to assist healthcare facilities in managing the demand for rehabilitation in the territory using a 'digital' therapist. The main objective of this project is therefore to identify the appropriate technology to administer the rehabilitation programme to patients and apply to a group of post-COVID-19 patients a customised respiratory and/or motor rehabilitation programme to be carried out directly at the patients' home after hospital discharge in order to evaluate its effects.


Eligibility criteria: Inclusion Criteria:

* Adult patients admitted to a rehabilitation facility for functional recovery in disabling motor and/or respiratory outcomes of severe acute respiratory syndrome COronaVirus 2 (SARS-CoV2) infection and residing in cross-border regions with a low density of rehabilitation offerings.

Exclusion Criteria:

* Psychiatric disorders/cognitive impairments that do not allow proper use of tablets and breathing training devices.

Primary outcomes:
measure: Change from baseline aerobic endurance.
timeFrame: up to 8 weeks
measure: Change from baseline balance and functional mobility.
timeFrame: up to 8 weeks
measure: Change from baseline isometric strength.
timeFrame: up to 8 weeks
measure: Change from baseline in several respiratory measures.
timeFrame: up to 8 weeks
measure: Change from baseline in the pulmonary function test.
timeFrame: up to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Oggebbio
country: Italy
facility: Istituto Auxologico Italiano IRCCS
state: VB
city: Brissago
country: Switzerland
facility: Clinica Hildebrand
Study officials:
affiliation: Politecnico di Milano
name: Veronica Cimolin
role: PRINCIPAL_INVESTIGATOR
References: