louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06554197: Evaluation of CMV/EBV-CMI in Haploid HSCT
Official title: Evaluation of Cytomegalovirus and Epstein-Barr Virus Specific Immune Reformulation in Prophylaxis for Cytomegalovirus in Haploid Hematopoietic Stem Cell Transplantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hematopoietic Stem Cell Transplantation
Cytomegalovirus Infections
Epstein-Barr Virus Infections
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2024-08-15
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are diagnosed with hemopathy and should have the indication of Haploidentical hematopoietic stem cell transplant and receive the prophylaxis for cytomegalovirus.

Brief summary: The purpose of this prospective, open-label, Single Arm, single-center study is to evaluate the cytomegalovirus and Epstein-Barr virus specific immune reestablishment for patients with hemopathy undergoingin prophylaxis for cytomegalovirus in haploid hematopoietic stem cell transplantation(haplo-HSCT) .


Eligibility criteria: Inclusion Criteria:

1. All patients were diagnosed with hemopathy.
2. All patients should have the indication of Haploidentical hematopoietic stem cell transplant and receive the prophylaxis for cytomegalovirus.
3. All patients should sign an informed consent document indicating that they understand the purpose of and procedures required for the study and be willing to participate in the study.

Exclusion Criteria:

Patients with any conditions not suitable for the trial (investigators' decision).

Primary outcomes:
measure: CMV-CMI
timeFrame: 6 months after transplantation
measure: EBV-CMI
timeFrame: 6 months after transplantation
Secondary outcomes:
measure: Cumulative incidence of CMV reactivation
timeFrame: 1 years after transplantation
measure: Cumulative incidences of EBV reactivation
timeFrame: 1 years after transplantation
measure: Overall survival (OS)
timeFrame: 1 years after transplantation
measure: Non-relapse mortality (NRM)
timeFrame: 1 years after transplantation
measure: Relapse-related mortality (RRM)
timeFrame: 1 years after transplantation
measure: GVHD-free and relapse-free survival (GRFS)
timeFrame: 1 years after transplantation
measure: Cumulative incidences of aGVHD
timeFrame: 100 days after transplantation
Other outcomes:
Locations:
city: Suzhou
country: China
facility: First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
References:
Clinical trial NCT01703897: Esophageal Manometry and Impedance Study in Obese Patients Before and During Anesthesia
Official title: Evaluation of Esophageal Pressures and Reflux in Obese Patients Before and During Anesthesia Using High-resolution Solid-state Manometry
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Obesity
Keywords: gastric by-pass surgery
Lead sponsor: Örebro University, Sweden
Sponsor class: OTHER
First posted: 2012-10-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Obese patients

Brief summary: The purpose of this study is to evaluate the effects of anesthesia on the esophageal body in obese patients before and during anesthesia.

Detailed description: Obesity is an increasing heath problem in western countries and is associated with increased risks during anesthesia.

Using high-resolution solid-state manometry the investigators aim to study esophageal pressures and measure the incidence of regurgitation of gastric contents during anesthesia induction in obese patients. The investigators aim to include 16 obese patients, with BMI \> 35, undergoing laparoscopic gastric by-pass.

Eligibility criteria: Inclusion Criteria:

* Male and female patients
* aged 18-60 years
* BMI\>35
* ASA classification I-III

Exclusion Criteria:

* Use of drugs that interfere with esophageal motility
* Gastro-esophageal reflux disease

Primary outcomes:
measure: Esophageal pressures after laparoscopic gastric by pass
timeFrame: 2 years after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Department of Anesthesiology and Intensive care, University Hospital of Örebro
Study officials:
References:
Clinical trial NCT00753597: Rescue of Steroidogenic Capacity in Adrenocortical Failure Study (RADS)
Official title: Immunotherapeutic Rescue of Steroidogenic Function in Autoimmune Adrenocortical Failure: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Autoimmune Adrenocortical Failure
Keywords: B cell depletion
steroidogenesis
Lead sponsor: Newcastle University
Sponsor class: OTHER
Collaborators: name: Newcastle-upon-Tyne Hospitals NHS Trust
First posted: 2008-09-16
Enrollment: 6
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is a pilot study of B lymphocyte depletion therapy in an attempt to salvage adrenal steroidogenic capacity in ten subjects with early autoimmune Addison's disease. During the first twelve weeks of treatment, additional glucocorticoid therapy (prednisolone) will be given to ensure wellbeing and to rest the steroidogenic apparatus that is the target of the autoimmune attack. Glucocorticoids will be gradually withdrawn, in a controlled fashion, and adrenal function re-evaluated at 13, 26, 39 and 52 weeks. The primary endpoint will be restoration of steroidogenic function as judged by conventional endocrine indices of adrenocortical function. B cell depletion may ameliorate the autoimmune attack against adrenal cells, potentially allowing a state of immune tolerance to be restored with subsequent recovery of adrenal steroidogenic capacity.


Eligibility criteria: Inclusion Criteria:

* Clear evidence of primary adrenal failure (elevated ACTH, pigmentation, electrolyte disturbance)
* Basal or stimulated cortisol \<400 nmol/l but \>100nmol/l

Exclusion Criteria:

* Active viral infection, pregnancy or breast feeding, previous immunosuppression, diabetes, cardiorespiratory disease, renal failure, hepatic disease, cancer
* Calcified or enlarged adrenals on CT scan, active TB

Primary outcomes:
measure: Peak serum cortisol, basal or post ACTH
timeFrame: 13, 26, 39, 52 weeks from first treatment
Secondary outcomes:
measure: 21-OHase antibodies
timeFrame: 13, 26,39, 52 weeks
Other outcomes:
Locations:
city: Newcastle upon Tyne
country: United Kingdom
facility: Clinical Research Facility, Royal Victoria Infirmary
Study officials:
affiliation: Newcastle University
name: Simon Pearce, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pearce SH, Mitchell AL, Bennett S, King P, Chandran S, Nag S, Chen S, Smith BR, Isaacs JD, Vaidya B. Adrenal steroidogenesis after B lymphocyte depletion therapy in new-onset Addison's disease. J Clin Endocrinol Metab. 2012 Oct;97(10):E1927-32. doi: 10.1210/jc.2012-1680. Epub 2012 Jul 5.
Clinical trial NCT06603597: HER2-positive Breast Cancer Registry
Official title: Prospective Evaluation of Outcomes for HER2-positive Breast Cancer (PRO-HER2)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HER2 + Breast Cancer
Keywords: breast cancer
registry
HER2+
HER2 positive
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with stage I-IV HER2-positive breast cancer.

Brief summary: The goal of this observational study is to better understand links between patient or tumor characteristics and outcomes in HER2-positive breast cancer.


Eligibility criteria: Inclusion Criteria:

* Stage I-IV HER2-positive breast cancer

Exclusion Criteria:

* None

Primary outcomes:
measure: Overall survival rate
timeFrame: From diagnosis to 5 years after diagnosis
Secondary outcomes:
measure: Pathologic complete response rate
timeFrame: From start of neoadjuvant systemic treatment until approximately 8 months after start of neoadjuvant systemic treatment
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: KUCC - Indian Creek
state: Kansas
city: Overland Park
country: United States
facility: KCCC Overland Park
state: Kansas
city: Westwood
country: United States
facility: The University of Kansas Cancer Center
state: Kansas
city: Kansas City
country: United States
facility: KUCC - North
state: Missouri
city: Lee's Summit
country: United States
facility: KUCC - Lee's Summit
state: Missouri
Study officials:
References:
Clinical trial NCT05117697: Surgical Treatment of a Chronic Anal Fissure
Official title: Treatment of Chronic Anal Fissure by Performing a Lateral Subcutaneous Sphincterotomy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Anal Fissure
Lead sponsor: State Scientific Centre of Coloproctology, Russian Federation
Sponsor class: OTHER_GOV
First posted: 2021-11-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment

A comparative,randomized, prospective, single-center clinical study. Patients of the main group are treated with a crack by performing a lateral subcutaneous sphincterotomy.

In the control group, the fissure is excised in combination with a lateral subcutaneous sphincterotomy.
Primary purpose: TREATMENT

Brief summary: This study is aimed at studying the effectiveness and safety of surgical treatment of chronic anal fissure.

Detailed description: A chronic anal fissure is a rupture of the mucous membrane of the anal canal, lasting more than 2 months and resistant to non-surgical treatment. This condition is accompanied by a strong pain syndrome during and after defecation (defecation). This condition is most often found in young and able-bodied adults, so the issue of treatment is of particular relevance.

The main cause of the development of a chronic anal fissure is a spasm of the internal sphincter. It should be eliminated first of all to ensure effective therapy.The investigators plan to treat a chronic anal fissure by performing a lateral subcutaneous sphincterotomy, without excision of the fissure.

Eligibility criteria: Inclusion Criteria:

* Patients with chronic anal fissure

Exclusion Criteria:

* Inflammatory diseases of the colon
* Pectenosis
* Previous surgical interventions on the anal canal
* IV grade internal and external hemorrhoids
* Rectal fistula
* Severe somatic diseases at the decompensation stage
* Pregnancy and lactation
* Anal sphincter insufficiency

Primary outcomes:
measure: Anal sphincter insufficiency
timeFrame: Up to 60 days
Secondary outcomes:
measure: 2-item pain intensity (P2)
timeFrame: On day 7, 30 and 60
measure: Non-Healing Wound
timeFrame: On day 60
measure: Profilometry /sphincterometry findings
timeFrame: On day 30 and 60
measure: Temporary disability
timeFrame: Up to 60 days
measure: Relap
timeFrame: Up to 60 days
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: SSCCRussia
city: Moscow
country: Russian Federation
facility: Nikolay Goloktionov
Study officials:
References:
Clinical trial NCT05423197: Study Evaluating Zr-Panitumumab for Assessment of Suspected Metastatic Lesions on 18F-FDG-PET/CT in Head and Neck Squamous Cell Carcinoma
Official title: Phase II Study Evaluating Zr-Panitumumab for Assessment of Suspected Metastatic Lesions on 18F-FDG-PET/CT in Head and Neck Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Head-and-neck Squamous Cell Carcinoma
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine the diagnostic utility of 89Zr-panitumumab to identify metastatic lesion(s) in subjects with head and neck squamous cell carcinoma (HNSCC).

Detailed description: PRIMARY OBJECTIVE(S):

- Determine the sensitivity and specificity of 89Zr-panitumumab for the detection of suspected metastatic lesions

SECONDARY OBJECTIVE(S):

- Compare sensitivity and specificity of 18F-FDG-PET/CT and 89Zr-panitumumab-PET/CT for detection of suspected metastatic lesions

Eligibility criteria: Inclusion Criteria:

* Age ≥ 19 years.
* Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck.
* Subjects diagnosed with any T stage, any subsite within the head and neck. Subjects with recurrent disease or a new primary will be allowed.
* Must have standard of care 18F-FDG-PET/CT scan ≤ 30 days of Day 0 with suspected metastatic lesions.
* Have acceptable hematological status, coagulation status, kidney function, and liver function including the following clinical results:

  * Hemoglobin ≥ 9gm/dL
  * White blood cell count \> 3000/mm3
  * Platelet count ≥ 100,000/mm3
  * Serum creatinine ≤ 1.5 times upper reference range
  * PTT = 11.5 - 14.4 seconds
  * INR = 0.9 - 1.2

Exclusion Criteria:

* Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment
* History of infusion reactions to other monoclonal antibody therapies
* Pregnant or breastfeeding
* Magnesium or potassium lower than the normal institutional values
* Subjects receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
* Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
* Severe renal disease or anuria
* Known hypersensitivity to deferoxamine or any of its components

Primary outcomes:
measure: Sensitivity and Specificity of 89Zr-panitumumab
timeFrame: Up to 1 year
Secondary outcomes:
measure: Sensitivity and Specificity 89Zr-panitumumab compared to standard of care 18F-FDG PET/CT imaging
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Stanford Cancer Institute
state: California
Study officials:
affiliation: Stanford Cancer Institute
name: Judy Nguyen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00806897: Observational Study in Type 2 Diabetics Treated by an Intensive Insulin Treatment of Levemir®
Official title: Prospective, Multicentre, Open Label, Non-controlled, 24-week Observation in Type 2 Diabetics Using Once Daily Levemir® (Insulin Detemir) as Part of Their ITT Regimen
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-12-11
Enrollment: 74
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: Diabetic subjects from specialists' (diabetologists, internists) care who are treated with intensive insulin treatment by prescription in line with governing prescribing rules. At baseline subjects are treated with IIT containing NPH as basal insulin.

Brief summary: This study is conducted in Europe. The aim of this observational study is to gain practical experience with once daily Levemir® administration in type 2 diabetes patients who were previously treated with NPH insulins (e.g. Protaphane®) as basal insulin as part of their IIT under normal clinical practice conditions in Lithuania


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetic subjects on intensive insulin treatment (IIT)
* Eligibility for once daily insulin detemir administration
* Informed consent obtained before any observation-related activities

Exclusion Criteria:

* Known or suspected allergy to insulin detemir
* Subjects previously enrolled in the observation
* Women who are pregnant, breast feeding or have the intention of becoming pregnant within 6 months

Primary outcomes:
measure: Change in HbA1c from baseline
timeFrame: at 24 weeks
Secondary outcomes:
measure: Change in body weight
timeFrame: at 12 weeks/24weeks
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06971497: Zimmer ActivBraid Rotator Cuff Repair (RCR) Study
Official title: Cleveland Clinic ActivBraid Rotator Cuff Repair (RCR) Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Rotator Cuff Repair of the Shoulder
Keywords: rotator cuff repair
shoulder
rotator cuff tear
collagen suture
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Zimmer Biomet
First posted: 2025-05-14
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing primary arthroscopic rotator cuff repair

Brief summary: We will enroll up to 65 patients undergoing primary arthroscopic rotator cuff repair (RCR) using ActivBraid™Collagen Co-Braid suture (Zimmer Biomet) and evaluate RCR healing as well as shoulder range of motion, strength, and patient-reported outcomes at 6m, 1y and 2y.


Eligibility criteria: Inclusion Criteria:

* 18-75 years
* acute or chronic, reparable, 1-5 cm full thickness tear of the supraspinatus and/or infraspinatus tendons

Exclusion Criteria:

* prior ipsilateral shoulder surgery
* outstanding worker's compensation claim
* symptomatic cervical spine disease
* a frozen shoulder
* advanced glenohumeral arthritis
* isolated subscapularis tear
* significant radiation exposure for other medical reasons.
* known is advance to be claustrophobic
* known history of hypersensitivity to bovine-derived materials.

Primary outcomes:
measure: Rotator cuff repair healing
timeFrame: 1 year post-operation
measure: Rotator cuff repair healing
timeFrame: 1 year post-operation
Secondary outcomes:
measure: Patient-reported outcome measures
timeFrame: 1 year post-operation
measure: Shoulder strength
timeFrame: 1 year post-operation
measure: Shoulder range of motion
timeFrame: 1 year post-operation
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Kathleen Derwin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Eric Ricchetti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05047497: Ventilatory Functions, Oxygen Saturation, and Quality of Life Response to Long Time Cement Dust Exposure
Official title: Ventilatory Functions, Oxygen Saturation, and Quality of Life Response to Long Time Cement Dust Exposure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Occupational Diseases
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-09-17
Enrollment: 49
Sex: MALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Out of sixty persons who were assigned to this study, a total of 49 subjects (group 1 n = 18, group 2 n = 13 and group 3 n = 18) completed the study (Fig. 1).

In all groups, A, B and, C; height and weight scale were obtained for calculating BMI. The distribution of smokers between different age groups was measured (table ) The pulmonary function tests were performed to evaluate the capacity and volume of the lungs among the participants. Spirometry measurements, including FVC, FEV1, ratio of FEV1 to FVC (FEV1/FVC), forced expiratory flow 25-75% (FEF 25-75%), and peak expiratory flow (PEF

Brief summary: Thousands of people are working daily in a dusty environment. Many studied reported respiratory symptoms and ventilatory disorders among Factory workers who exposed to cement dust. But the evidence for respiratory effect and daily activities over a long time of cement dust exposure has not been conclusive

Detailed description: A total of 49 subjects working in a cement production factory were assessed and divided into three groups according to the total period of work exposure. Groupe A (18 subjects) with work period \< 10 years, group B (13 subjects) with work period 10-15 years, group C (18 subjects) with work period \> 15 years. The ventilatory functions, oxygen saturation, and quality of life were assessed in the three groups. RESULTS: The study results revealed a statistically significant difference between the three groups in the mean values of FVC (%), FEV1/FVC (%), SPO2.

Eligibility criteria: Inclusion Criteria:

* The ages were between 25 to 50 years old.
* the body mass index ranged from (18,5 - 29,9) kg/m2.

Exclusion Criteria:

* Age less than 25 or more 50.
* Any chronic diseases
* severe musculoskeletal and cardiopulmonary disorders and
* Class III Obesity (35-39.9 kg/m 2) or more

Primary outcomes:
measure: The ventilatory functions
timeFrame: 8 months
measure: oxygen saturation
timeFrame: 8 months
measure: quality of life were assessed
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of physical therapy Cairo university
Study officials:
References: