louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00994669: Development of a Non-invasive Assessment of Skeletal Muscle Loss in Cancer Patients
Official title: Development of a Non-invasive Assessment of Skeletal Muscle Loss in Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cachexia
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-10-14
Enrollment: 17
Sex: MALE
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample of healthy males and male lung cancer patients

Brief summary: The long-term objective of this research is to develop a non-invasive approach for early assessment of which patients are at high risk for future development of skeletal muscle atrophy. The investigators hypothesize that the rate constant for the terminal portion of the isotope decay curve following ingestion of a single oral dose of deuterated-3-methylhistidine (D-3MH) provides an accurate measure of this increased risk and that this rate constant can be measured non-invasively from timed spot urine samples. In addition, the investigators hypothesize that ingestion of a meat-containing meal will stimulate synthesis of skeletal muscle proteins to a greater extent than a non-meat-containing meal.


Eligibility criteria: Inclusion Criteria:

* male
* 30-85 years
* Body Mass Index (BMI) \<30 kg/m2

Exclusion Criteria:

* Uncontrolled hypertension
* Glomerular filtration rate less than 60 mL/min/1.73 m2
* History of recurrent gastrointestinal bleeding
* Unable or unwilling to provide informed consent
* Ongoing anti-coagulant therapy

Primary outcomes:
measure: Assessment of the slope of terminal D-3MH/3MH decay curve post-dosing.
timeFrame: Post-dosing 12 to 22 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: University of Texas
name: Melinda Sheffield-Moore, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02068469: In Vitro Diagnostic Device for the Detection of Strep A
Official title: Multi-Center Study of an In Vitro Diagnostic Device for the Detection of Strep A
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Streptococcal Sore Throat
Lead sponsor: IQuum, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Roche Molecular Systems, Inc
First posted: 2014-02-21
Enrollment: 799
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult and Pediatric primary care clinic, walk in clinic

Brief summary: The purpose of this trial is to show the accuracy and specificity of the Liat analyzer and assay for detecting Strep A at the point of care lab compared to culture.


Eligibility criteria: Inclusion Criteria:

* Subjects who are 3 years of age or older
* Subjects exhibiting symptoms characteristic of pharyngitis, possibly Streptococcus A, including:

  * presence of sore throat, and at least one other symptom from the list below:
  * redness of the posterior pharyngeal wall
  * pharyngeal or tonsillar exudate
  * tonsillar swelling
  * tender cervical lymphadenopathy
  * fever, \>38C at presentation or within the past 24 hours
* Subjects who are able to understand and consent to participation; for minors under the age of 18, this includes parent or legal guardian

Exclusion Criteria:

* Subjects treated with antibiotics currently or within the previous 7 days.

Primary outcomes:
measure: Evaluate sensitivity and specificity of the Liat Strep A assay when compared to culture
timeFrame: Results based on samples collected at initial visit
Secondary outcomes:
Other outcomes:
Locations:
city: Norwich
country: United States
facility: Norwich Pediatrics
state: Connecticut
city: Savannah
country: United States
facility: Meridian Clinical Research
state: Georgia
city: Rochester
country: United States
facility: Twelve Corners Pediatrics
state: New York
city: Plano
country: United States
facility: Plano Pediatrics
state: Texas
city: Vienna
country: United States
facility: Advanced Pediatrics
state: Virginia
Study officials:
affiliation: IQuum COO
name: Lingjun Chen, BS
role: STUDY_DIRECTOR
References:
Clinical trial NCT00126269: Trial Comparing Cisplatin With or Without Gemcitabine in Patients With Carcinoma of Unknown Primary
Official title: A Randomized Phase III Trial Comparing Cisplatin With or Without Gemcitabine in Patients With Carcinoma of Unknown Primary and a Predicted Favorable Prognosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Carcinoma
Keywords: Patients with Carcinoma of Unknown Primary and a Predicted Favorable Prognosis
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2005-08-03
Enrollment: 192
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: This is a randomized phase III trial comparing cisplatin with or without gemcitabine in patients with carcinoma of unknown primary and a predicted favorable prognosis.

The purpose of this trial is to compare the overall survival rates of patients with carcinoma of unknown primary (CUP) and a predicted favorable prognosis according to the French classification treated with cisplatin with or without gemcitabine.


Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years
* Evidence of CUP based on histologic examination
* Negative search for the primary tumor site using recommended guidelines
* Disease classified as good prognosis according to the French classification criteria: \*performance status \>2 and \*normal serum LDH
* No prior chemotherapy
* No previous carcinoma, except basal-cell carcinoma of the skin
* Adequate renal function: measured or calculated creatinine clearance \> 60 ml/min
* Absolute granulocyte count ≥ 1,500/mm3; platelets ≥ 100,000 mm3; bilirubin ≤ 1.5 fold the upper normal value
* Signed informed consent

Exclusion Criteria:

* Patients infected by the Human Immunodeficiency Virus (HIV)
* CUP belonging to one of the following subgroups: 1) Axillary lymph node of an adenocarcinoma in a woman; 2) Serous adenocarcinoma of the peritoneum in a woman; 3) Undifferentiated carcinoma of the middle line in a young man; 4)Squamous-cell carcinoma; 5) Neuroendocrine carcinoma; 6) Bone metastases with elevated serum prostate specific antigen (PSA) in a man
* Patients who do not fit inclusion criteria.

Primary outcomes:
measure: Overall survival
Secondary outcomes:
measure: Response rate
measure: Progression-free survival
measure: Toxicity
measure: Quality of life
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Karim FIZAZI, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04420169: Uniform Communication by Midwives in Preparation for an IVF Treatment
Official title: Uniform Communication by Midwives in Preparation for an IVF Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Communication
IVF
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 105
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Dutch-speaking women who are about to start an IVF treatment at our department.

Brief summary: Dutch-speaking women who are about to start an IVF treatment will be approached. If they are willing to participate in the study, they will receive an email with a link to an online questionnaire. This questionnaire will evaluate the communication by the midwive in preparation for an IVF treatment. When 50 women have completed the questionnaire a standardized communication protocol will be enrolled. Once all midwives are trained, 50 other IVF patients will be asked to complete the slightly adapted post questionnaire.The data from both questionnaires will be compared.


Eligibility criteria: Inclusion Criteria:

* women who are about to start an IVF treatment at our department

Exclusion Criteria:

* non-Dutch speaking
* women who are counseled by one of the midwives involved in the design of this study

Primary outcomes:
measure: How do patients evaluate the communication by the midwife in anticipation of the IVF treatment cycle?
timeFrame: About 20 weeks counting from the launch of each questionnaire or earlier if the target of 50 patients is reached sooner
Secondary outcomes:
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Ghent University Hospital
Study officials:
References:
Clinical trial NCT03256669: Umblical Incision for Neonatal Surgery
Official title: Umblical Incision for Neonatal Surgey; is it Suitable
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Surgery
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-08-22
Enrollment: 7
Sex: ALL
Minimum age (years): 20
Maximum age (years): 20
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Abdominal exploration leave an ugly scar that live with the baby forever, laparoscopy can solve the problem to some extent by making a smaller scar but takes more time and need special surgical skills. Umbilical incision can combine the advantage of open and laparoscopy and avoid the drawbacks of both.

Detailed description: six cases were subjected to the study 2 cases have duodenal atresia, one case has annular pancreas, one case has jujenal atresia chritmas tree, one case has jujenal web and a case of malrotation. all of them had made exploration by the umbilical incision, and no drains had been used.

Eligibility criteria: Inclusion Criteria:

* neonate diagnosed radiologically

Exclusion Criteria:

* unclear diagnosis

Primary outcomes:
measure: operative time
timeFrame: 2 hours
Secondary outcomes:
measure: cosmotic appearance
timeFrame: 2 weeks
Other outcomes:
measure: result
timeFrame: 1 week
Locations:
city: Asyut
country: Egypt
facility: Assiut University
Study officials:
References:
Clinical trial NCT00764569: The Investigation of a Fluorescence/Elastic Scattering Spectroscopy (F-ESS) Device for Oral Tissue Characterization
Official title: a Non-invasive Device for the Detection, Diagnosis and Screening of Oral Pathology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Other Lesions of Oral Mucosa
Keywords: oral tissue
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
First posted: 2008-10-02
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample

Brief summary: The overall objective of this work is to identify changes in the optical properties of oral tissues to develop a non-invasive tool for the detection, diagnosis and screening of oral pathology so that treatment can be provided at the earliest possible time.

Detailed description: Specifically, we will be obtaining optical spectroscopic data using a fiber optic contact probe that exploits elastic-scattering spectroscopy and fluorescence spectroscopy. Both of these technique have independently shown to provide signatures for the onset of cancer, with varied success. The purpose of this effort is to combine the two techniques and develop and understanding of the signatures obtained in both normal and abnormal oral tissue with simultaneous collection of these optical signatures.

Eligibility criteria: Inclusion Criteria:

* adult over 18 years of age

Exclusion Criteria:

* younger than 18 years of age

Primary outcomes:
measure: Diagnostic Tool
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Laser Institute Medical clinic
state: California
city: Irvine
country: United States
facility: UCI student health center
state: California
Study officials:
affiliation: Beckman Laser Institute University of California Irvine
name: Petra Wilder-Smith, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03699969: A Study Comparing Hypofractionated Dose Escalated VMAT to Conventional CCRT in Locally Advanced Head and Neck Cancer
Official title: A Clinical Study Comparing Hypofractionated Dose Escalated VMAT to Conventional CCRT in Locally Advanced Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Locally Advanced Head and Neck Cancer
Keywords: Hypofractionation
VMAT
head and neck cancer
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 63
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: TREATMENT

Brief summary: To compare efficacy and toxicity between hypofractionated dose escalated VMAT versus conventional concurrent chemoradiation in locally advanced head and neck cancer

Detailed description: patients were randomized to receive either: 70Gy in 35fx in 7wks at 2Gy/fx concurrently with weekly cisplatin 40mg/m2 (Arm A) or 74Gy in 33 fractions (fx) in 6.5 weeks at 2.24Gy/fx (Arm B). Volumetric Modulated Arc Therapy (VMAT) plans were created for both treatment arms

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years and ≤70 years old.
2. Histopathologically confirmed squamous cell carcinoma of head and neck.
3. Locally advanced tumors (T3-T4 \&/or N1-3) (stage IIB, III and stage IV-A: Staging by AJCC 7th edition).
4. Patients not exposed to radical surgery for current disease.
5. Performance status (ECOG) 2 or less.
6. No associated co-morbidity with contraindication to chemotherapy.
7. Normal Hemogram. (ANC ≥1.5x109/L, Platelets count ≥100x109/L, hemoglobin ≥80 g/L)
8. Accepted renal functions. (BUN \& serum creatinine \<1.5x upper limit of normal value with normal GFR).
9. Accepted liver functions. (total bilirubin and direct bilirubin \< 1.5 x ULN \& alanine aminotransferase and aspartate aminotransferase \< 3 x ULN)
10. Informed consent.

Exclusion Criteria:

1. Patients with distant metastatic lesions, as detected by imaging techniques.
2. Patients with history of other head and neck malignancies.
3. Patients with history of previous head and neck irradiation.
4. Patients with a serious concomitant illness, such as active cardiac disease, severe uncontrolled hypertension, or uncontrolled infection.
5. Women who are pregnant or breast feeding.

Primary outcomes:
measure: Local control in the two arms
timeFrame: 33 months
Secondary outcomes:
measure: The progression free survival in the two arms
timeFrame: 33 months
measure: The incidence of toxicity of radiotherapy by CTCAE protocol in the two arms
timeFrame: 33 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01840969: Association of Carotid Arterial Circumferential Strain With Left Ventricular Function and Hemodynamic Compromise During Off-pump Coronary Artery Bypass Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Three Vessel Coronary Artery Disease
Keywords: off-pump coronary artery bypass surgery
common carotid artery
speckle tracking analysis
peak strain
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-04-26
Enrollment: 96
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for elective multivessel off-pump coronary artery bypass surgery

Brief summary: This study is aimed to evaluate the association of common carotid artery circumferential strain with the echocardiographic parameters of left ventricular function and the degree of actual hemodynamic deterioration in patients undergoing multi-vessel off-pump coronary artery bypass with preserved left ventricular ejection fraction.


Eligibility criteria: Inclusion Criteria:

1. three vessel coronary artery disease
2. sinus rhythm

Exclusion Criteria:

1. New York Heart Association functional class ≥3
2. known pulmonary hypertension
3. known valvular heart disease
4. serum creatinine ≥2.0 mg/dL
5. myocardial infarction within 1 week before the surgery
6. history of cerebral or peripheral arterial occlusive disease

Primary outcomes:
measure: TTE parameters
timeFrame: 1 day before the surgery
Secondary outcomes:
measure: change of intraoperative hemodynamic variables
timeFrame: from after induction of anesthesia, left circumflex artery grafting, and to sternum closure
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT04088669: Efficiency of Home-Based Pulmonary Rehabilitation in Adults With Asthma
Official title: Efficiency of Home-Based Pulmonary Rehabilitation in Adults With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Rehabilitation
Asthma
Home-based Pulmonary Rehabilitation
Keywords: asthma
pulmonary rehabilitation
home-based pulmonary rehabilitation
home-based rehabilitation
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2019-09-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Asthma is a serious global health problem affecting people of all ages in every country in the world. Despite the presence of effective medications, many studies have reported poor asthma control in patients. Therefore, new approaches are needed to improve asthma control. Pulmonary rehabilitation is recommended as an alternative approach in patients with chronic lung disease including asthma. Also, home-based type of pulmonary rehabilitation can be preferred because it is more cost-effective and patients can spend more time with their families. There are a limited number of studies in the literature evaluating the efficacy of home-based pulmonary rehabilitation in asthmatic patients. The aim of this study was to investigate the efficacy of home-based pulmonary rehabilitation program with simple equipment in asthmatic patients.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with asthma
* Acceptance of persons to participate in the study
* Being in the 18-65 age range

Exclusion Criteria:

* Presence of an orthopedic, neurological, systemic disease that prevents the exercise
* Having mental, communicative and behavioral disorders that may cause problems in understanding commands and questions or practicing exercises.
* Exercising 3 or more days a week

Primary outcomes:
measure: Functional Capacity
timeFrame: 8 weeks
measure: Peak Expiratory Flow
timeFrame: 8 weeks
measure: Forced Expiratory Volume in 1 second
timeFrame: 8 weeks
measure: Control of Asthma
timeFrame: 8 weeks
measure: Dyspnoea
timeFrame: 8 weeks
Secondary outcomes:
measure: Lower Extremity Strength and Dynamic Balance
timeFrame: 8 weeks
measure: Health Related Quality of Life
timeFrame: 8 weeks
measure: Activity of Daily Living
timeFrame: 8 weeks
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Bezmialem Vakıf University
state: Eyüp
city: İstanbul
country: Turkey
facility: Bahçelievler Public Hospital
Study officials:
affiliation: Bezmialem Vakif University
name: Ayşe Sena Manzak, PhD Student
role: PRINCIPAL_INVESTIGATOR
affiliation: Bezmialem Vakif University
name: Semiramis Özyılmaz, Assoc. Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06320769: Role of Rotational Guided Growth in Management of Increased Femoral Anteversion
Official title: Role of Rotational Guided Growth in Management of Increased Femoral Anteversion
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Increased Femoral Anteversion
Keywords: Rotational Guided Growth
Torsional Deformities
Guided Growth
Rotational Deformities
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 15
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Efficacy of guided growth in coronal plane deformity correction and limb length discrepancy has been well-established. Recently, studies have explored the validity of guided growth in correction of rotational deformity through a modified method of application.

This concept has been validated in animal studies, biomechanical studies and two limited human case series through different methods.

This study evaluates the efficacy of rotational guided growth in management of increased femoral anteversion using three different constructs.

Detailed description: The purpose of this study is:

1. Evaluate the efficacy of different constructs in correcting increased femoral anteversion clinically and radiographically.
2. Asses possible complications of this new concept including LLD, undesired coronal, sagittal plane deformity and stiffness.

Eligibility criteria: Inclusion Criteria:

* Children with increased femoral anteversion causing in-toeing with decreased agility.
* Aged 8 years and above with at least two years of bone growth remaining.

Exclusion Criteria:

* Any patient who underwent previous femoral osteotomy.
* Any patient with sick physis (skeletal dysplasias, post traumatic / post infective physeal damage, active rickets).
* Cerebral Palsy (CP) patients

Primary outcomes:
measure: Gait
timeFrame: 12 months
Secondary outcomes:
measure: Limb length discrepancy
timeFrame: 12 months
measure: Angular Deformities
timeFrame: 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine, Ainshams University
state: El-Waily
Study officials:
affiliation: Ain Shams University
name: Tarek Hassan Abdelaziz, Professor
role: STUDY_CHAIR
References: