louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00597311: Preoperative Chemoradiation Versus Short Term Radiation Alone With Delayed Surgery for Stage II and III Resectable Rectal Cancer
Official title: Preoperative Chemoradiation Versus Short Term Radiation Alone With Delayed Surgery for Stage II and III Resectable Rectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Primary Rectal Cancer
Keywords: rectal cancer
radiotherapy
radiochemotherapy
Lead sponsor: Kaunas University of Medicine
Sponsor class: OTHER
First posted: 2008-01-18
Enrollment: 150
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: Trial compares two preoperative stage II and III rectal cancer treatment strategies: short term radiotherapy 5x5 Gy and delayed surgery after 6 weeks versus conventional chemoradiotherapy 50 Gy + 5Fu/Lv and surgery also after 6 weeks.


Eligibility criteria: Inclusion Criteria:

* histologically confirmed stage II and III rectal cancer less than 15 cm from anal verge
* less than 80 years old
* no other cancer during 5 years period
* compensate cardiovascular, pulmonary, hepatic and renal functions.

Exclusion Criteria:

* stage I or IV rectal cancer
* other cancer in 5 years period
* radiotherapy or chemotherapy in anamnesis
* not compensate cardiovascular, pulmonary, hepatic or renal functions, neurological, psychiatric disease, sepsis, etc.
* pregnancy or baby feeding

Primary outcomes:
measure: 5 years overall and disease free survival
timeFrame: 5 years
measure: recurrence rate
timeFrame: 5 years
Secondary outcomes:
measure: pathological "complete response" and downstaging rates
timeFrame: 5 years
measure: Impact on sphincter sparing operation rates
timeFrame: 5 years
measure: morbidity and mortality rates
timeFrame: 5 years
measure: Impact on quality of surgical resection
timeFrame: 5 years
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: KMUH, surgery department
Study officials:
affiliation: Kaunas Medical University
name: Dainius Pavalkis, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Latkauskas T, Pauzas H, Kairevice L, Petrauskas A, Saladzinskas Z, Janciauskiene R, Gudaityte J, Lizdenis P, Svagzdys S, Tamelis A, Pavalkis D. Preoperative conventional chemoradiotherapy versus short-course radiotherapy with delayed surgery for rectal cancer: results of a randomized controlled trial. BMC Cancer. 2016 Dec 1;16(1):927. doi: 10.1186/s12885-016-2959-9.
Clinical trial NCT01853111: Withdrawal of Immunosuppression in Recipients of Face and Extremity Transplants
Official title: Biomarker-guided Withdrawal of Immunosuppression in Recipients of Vascularized Composite Tissue Transplants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Vascularized Composite Allotransplantation
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Beth Israel Deaconess Medical Center
First posted: 2013-05-14
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Many patients suffer from devastating injuries to vascularized composite tissues. Vascularized composite tissues are blocs of functional tissue that can contain multiple tissue types such as bone, muscle, nerves, blood vessels, tendons, ligaments, and others. Examples of patients with severe vascularized composite tissue defects include limb amputees, patients with third-degree burns to the face or extremities, soldiers with improvised-explosive-device blast injuries to the face, and others. These patients cannot be helped satisfactorily with conventional reconstructive surgery; however, recently vascularized composite allotransplantation (VCA) such as transplantation of faces and limbs became available to this patients. Unfortunately, at this juncture, patients who receive VCA must submit to life-long regime of immunosuppressant drugs with serious side effects such as infection, renal toxicity and cancer. Immune tolerance is the absence of a destructive immune response from the recipient's body to the transplant, while otherwise maintaining sufficient immune function to fight infections and other threats. Transplant recipients with immune tolerance do not need to take immunosuppression drugs. The investigators believe that they can achieve immune tolerance in recipients of face and limb transplants.


Eligibility criteria: Inclusion Criteria:

* adults who have received VCA transplants at Brigham and Women's Hospital
* no less than 3 months elapsed since VCA transplant,
* on steroid-free immune dual immunosuppression with tacrolimus (6-8 ng/ml trough levels) and mycophenolate mofetil,
* no current concerns of rejection

Exclusion Criteria:

* recent (\<3 months) episodes of rejection,
* active bacterial or viral infection,
* malignancy,
* non-healing wounds
* pregnancy

Primary outcomes:
measure: Complete cessation of immune suppression without evidence of rejection for more than 6 months.
timeFrame: 6 -24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Bohdan Pomahac, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02512211: Validation of Questionnaires HAL and HEP
Official title: Spanish Validation of "Haemophilia Activities List" (HAL) and "Specific Sport Scale" (HEP-Test-Q) Questionnaires
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Haemophilia
Keywords: Hemophilia
Validation
Questionnaires
Activities
Sport
Patients
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2015-07-30
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with haemophilia and parents of children with hemophilia around the country that will participate in study.

Brief summary: Spanish Validation of HAL and HEP questionnaire by double translation (English-Spanish-English), with a pilotage pediatric patients with hemophilia and adults and parents of children with hemophilia. The final validity will be obtained with a sample of 60-100 patients with hemophilia

Detailed description: Validation of the Spanish hemophilia specific questionnaires: HAL and HEP (adult version version version children and parents). To do this, there will be a double inverse translation, a pilotage of validity and clarity with a small sample of subjects and analysis of reliability and validity with more than 100 patients and parents of children with hemophilia to complete the validation.

Eligibility criteria: Inclusion Criteria:

* Patients with hemophilia A and B
* Parents of children with hemophilia A and B, under 18
* Patients who have previously signed the informed consent document

Exclusion Criteria:

* Patients with other congenital coaghulopatías (eg, Von Willebrand's disease)
* Patients with cognitive impairment, or oral or written understanding

Primary outcomes:
measure: Translation of the original questionnaire (English) to Spanish
timeFrame: 1 day (Screening visit)
measure: the translated version of the questionnaire
timeFrame: 1 day (Screening visit)
measure: Sending the questionnaire to a large sample of patients for final validation
timeFrame: 1 day (Screening visit)
Secondary outcomes:
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Universidad de Murcia
city: Murcia
country: Spain
facility: Universidad Católica San Antonio, Murcia
Study officials:
affiliation: Universidad Católica San Antonio
name: RUBEN CUESTA-BARRIUSO, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06063811: Ventricular Tachycardia Ablation in LVAD Patients
Official title: Characterization of Ventricular Tachycardia Ablation in End-stage Heart Failure Patients With Left Ventricular Assist Device
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ventricular Tachycardia
End-stage Heart Failure
Ventricular Arrythmia
LVAD (Left Ventricular Assist Device)
Keywords: Catheter Ablation
VT Ablation in LVAD patients
Lead sponsor: Universitätsklinikum Köln
Sponsor class: OTHER
First posted: 2023-10-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with end-stage heart failure and an implanted LVAD which underwent ablation of ventricular tachycardia will be included in this retrospective observational study.

Brief summary: The CHANNELED-Registry is a multicenter retrospective study to (1) systematically assess the mechanism and origin of ventricular tachycardia in patients with end-stage heart failure carrying an left ventricular assist device (LVAD) and (2) to evaluate procedural parameters and outcome of ventricular tachycardia ablation in this special subset of patients.


Eligibility criteria: Inclusion Criteria:

* All patients with end-stage heart failure with an LVAD implanted undergoing VT ablation

Exclusion Criteria:

* Patients \<18 years, pregnant women, patients undergoing VT ablation without an LVAD

Primary outcomes:
measure: Mechanism of ventricular tachycardia in LVAD patients (descriptive name of scale)
timeFrame: 12 month
measure: Number of patients with ventricular tachycardia recurrence in device interrogation (physiological parameter)
timeFrame: 12 month
measure: Mortality (physiological parameter)
timeFrame: 12 month
measure: Heart failure Hospitalization (physiological parameter)
timeFrame: 12 month
Secondary outcomes:
measure: Procedure duration (From groin puncture to sheath removal in minutes)
timeFrame: 12 month
measure: Fluoroscopy time (minutes)
timeFrame: 12 month
measure: Radiofrequency energy used for ablation (in watts; e.g. 40 Watts)
timeFrame: 12 month
measure: Number of patients suffering from intraprocedural complication (physiological parameter, e.g. hematoma)
timeFrame: 12 month
Other outcomes:
Locations:
Study officials:
affiliation: Heart Center University of Cologne
name: Jakob Lüker, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04663711: The Degree of Adherence of Pre-anesthetic Tests at Kasr Alaini Hospital to the NICE-Uk Guidelines
Official title: The Degree of Adherence of Pre-anesthetic Tests at Kasr Alaini Hospital to the NICE-Uk Guidelines, and Its Effect on Decision Making & Patient Outcome. Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Keywords: preoperative
Investigation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adult patients that will be scheduled for an elective general surgical operation during our study time frame

Brief summary: The aim of this study is to assess the effectiveness and usefulness of the current practice of various examinations ordered by anesthesiologists during the pre-anesthetic evaluation in patients who are intended for elective surgery in our hospital. We will also evaluate the effect of delay \& its value to predict postoperative complications.

Detailed description: For each preoperative requested test, we will determine whether the test is indicated based on the National Institute for Health and Clinical Excellence (NICE) guidelines and whether it was effective for adverse effects management or unnecessarily requested.

An adherent test was defined as a test that followed NICE, while a non-adherent test was defined as a test that included an over or under test. Normal test results are based on the laboratory reference range of normal values.

Eligibility criteria: Inclusion Criteria:

* All adult patients that will be scheduled for an elective general surgical operation during our study time frame.

Exclusion Criteria:

* Patients that are operated on an emergency basis.
* Pregnant females.
* patients scheduled for cardiothoracic and neurosurgical procedures.

Primary outcomes:
measure: Percentage of adherence test to NiCE-UK guidelines
timeFrame: 24 hours
Secondary outcomes:
measure: Percentage of overdone investigations
timeFrame: 24 hours
measure: Estimated cost of overdone investigations
timeFrame: 1 month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine
Study officials:
References:
Clinical trial NCT00239811: Long Term Efficacy and Safety of FTY720 in de Novo Adult Renal Transplant Recipients
Official title: A Two-year Extension to a One-year, Multicenter, Partially Blinded, Double Dummy, Randomized Study to Evaluate the Efficacy and Safety of FTY720 Combined With Reduced-dose or Full-dose Cyclosporine, USP [Modified] (Novartis Brand) and Corticosteroids Versus Mycophenolate Mofetil Combined With Full-dose Cyclosporine, USP [Modified] (Novartis Brand) and Corticosteroids, in de Novo Adult Renal Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Transplantation
Keywords: Transplantation, kidney, and organ transplant.
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-17
Enrollment: 684
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the long term safety and efficacy of FTY720 combined with cyclosporine and corticosteroids in patients receiving a kidney organ transplant


Eligibility criteria: Inclusion Criteria

* Patients who completed the 12 month core study
* Patients who gave written informed consent to participate in the study Exclusion Criteria
* Not applicable Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 36 months post transplant
measure: Permanent resumption of dialysis within 36 months post transplant
measure: Surgical removal of graft within 36 months post transplant
measure: Death within 36 months post transplant
measure: Withdrawal of consent, death, or lost to follow up within 36 months post transplant
measure: Serum creatinine, calculated creatinine clearance and urine-protein/creatinine ratio at Months 18, 24, 30 and 36
measure: FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at Months 18, 24, 30 and 36
measure: Absolute lymphocyte count at Months 18, 24, 30 and 36.
Secondary outcomes:
measure: Physical examinations at Months 18, 24, 30 and 36
measure: Vital signs at Months 18, 24, 30 and 36
measure: Electrocardiogram at Months 24 and 36
measure: Chest X-ray Months 24 and 36
measure: Safety laboratory tests 18, 24, 30 and 36
measure: Ophthalmic evaluations 18, 24, 30 and 36
measure: AEs and SAEs
measure: FTY720/CsA levels at Months 18, 24, 30 and 36
Other outcomes:
Locations:
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
Clinical trial NCT00906711: Analysis of Balance in the Aging Process
Official title: Analysis of Balance in the Aging Process
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aging
Keywords: Aging
Postural Balance
Lead sponsor: Universidade de Franca
Sponsor class: OTHER
First posted: 2009-05-21
Enrollment: 48
Sex: ALL
Minimum age (years): 10
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participants were selected in dependency of Unifran (University of France) and the homes of the neighborhood. The choice of groups was based according to the degree of functionality and independence in order to analyze the lack of balance in the process of aging.

Brief summary: Introduction: While growing older, it is possible to notice a decrease in the functional and physiological reserves in the organism which impairs the the abilities in the elderly in doing some tasks. A simple balance becomes a challenge.

Objective: To evaluate the functional balance in the aging process.

Methods: The group was formed by 48 people from 10 to 85 years old. The evaluation instruments are the Berg Balance Scale (BBS), the Performance Oriented Mobility Assessment (POMA), the Unipodal Support Test, the Functional Reach Test and the Romberg's Test.

Detailed description: 48 individuals of both sexes and aged between 10 and 85 years were chosen. These individuals were divided according to age, into four groups (each group containing 12 individuals, 6 men and 6 women): Group I (G1): 10 - 18, Group II (G2): 20 - 35; Group III (G3): 45 - 60, Group IV (G4): 65 - 85.

The instruments used for assessment of the balance were: (1) Berg Scale - consists of 14 items with common activities of daily life, with progressive degree of difficulty (2) Assessment of Gait and Balance for Performance Oriented (POMA), consists of a protocol that evaluates the static and dynamic balance, with operations similar to the activities of daily living, (3) Test Support Unipodal; (4) adapted Functional Reach Test, which assesses the stability in the standing position, (5) Test and Romberg Romberg's test Romberg-Barré or sensitized conducted in stable and unstable soil, and all positions were first with open eyes and then with closed eyes. The duration of each exposure was 30 seconds, with different positioning of the feet.

Eligibility criteria: Inclusion Criteria:

* Absence of the basic pathology that interferes directly in the balance

Exclusion Criteria:

* Neurological changes
* Cognitive impairment
* Orthopedic injury
* Use of orthoses for lower limb
* Obesity
* Exercise frequently (more than twice a week)
* The bearer of any commitment to stay in their standing position

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Universidade de Franca
name: Lislei Patrizzi
role: STUDY_DIRECTOR
References:
Clinical trial NCT03123211: Expanded Access to Veliparib
Official title: Expanded Access to Veliparib
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Solid Tumors With Documented BRCA, BARD, or PALB or Other Acceptable DNA Mutations or Anomalies That Are Scientifically Sound
Triple Negative Breast Cancer (TNBC)
High Grade Serous Ovarian Cancer
Patients Requiring Veliparib Suspension Formulation
Keywords: Expanded Access
Pre-approval Access
Compassionate Use
Special Access Program
Named Patient Basis
Special Access Scheme
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2017-04-21
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to veliparib prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria. EAP is also available for other indications where there is reasonable scientific basis for efficacy.

Detailed description: Expanded Access

Eligibility criteria: Inclusion Criteria:

* The patient has relapsed/refractory disease and exhausted all standard treatments.
* The patient has documented Breast Cancer (BRCA), BRCA associated RING domain (BARD), or Partner and Localizer of Breast Cancer (PALB) or other acceptable deoxyribonucleic acid (DNA) mutations.

Exclusion Criteria:

* The patient is eligible for a Poly Adenosine diphosphate ribose polymerase (PARP) inhibitor clinical trial.
* The patient has previously received a PARP inhibitor for the same disease.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01587911: Casinomacropeptide and Satiety
Official title: Characterization of the Physiological and Subjective Satiety Response to Preloads Varying in Bioactive Dairy Proteins
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lack of Satiety
Excess Intake of Macronutrients
Appetite Disorders
Keywords: Satiety
Food intake regulation
Appetite regulation
Dairy Protein
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2012-04-30
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: Assessing 5 different milk derived proteins versus placebo for appetite regulation and satiety, delivered via shake vehicle.

Detailed description: Assessing 5 different milk derived proteins versus placebo for appetite regulation and satiety, delivered via shake vehicle. Subjects will attend a 5 hour post-prandial study day. Subjects will keep food records 1 and 3 days prior to study visit, day of visit, and day after visit; food to be weighed using study provided dietary scale.

Eligibility criteria: Inclusion Criteria:

* Healthy
* Unrestrained (score ≤ 10 on the Eating Inventory (EI) questionnaire, Stunkard and Messick 1985)
* Women
* 18 years of age
* Consume a low/moderate protein diet (12-20% protein energy).
* Meet BMI criteria of 19 to 24 kg/m2 OR 29 to 34 kg/m2, inclusive.

Exclusion Criteria:

* Women who score ≥ 10 on the Beck Depression Inventory (BDI, Beck and Beamesdorfer 1974)
* Women who score ≥ 30 on Eating Attitudes Test (EAT, Garner and Garfinkel 1979),
* Have current or past (previous 1 year) medical conditions that may interfere with any of the outcomes of this study.
* Weigh less than 110 lbs
* Are currently or have been modifying diet or exercise patterns to gain or lose weight in previous 60 days
* Have unstable body weight (fluctuations of ≥ 5 kg in 60 day period)
* Are excessive exercisers or trained athletes
* Taking any medications that would affect appetite or any other study-described endpoint will also be excluded.
* Allergies or intolerances to foods consumed in the study.
* Smoker
* Pregnant/lactation

Primary outcomes:
measure: Post-prandial satiety
timeFrame: 6 hours
measure: Post-prandial satiety
timeFrame: 6 hours
Secondary outcomes:
measure: Extended satiety
timeFrame: 48 hours
Other outcomes:
Locations:
city: Davis
country: United States
facility: University of California, Davis (Ragle Human Nutrition Research Center)
state: California
Study officials:
affiliation: University of California, Davis
name: Britt Burton-Freeman, PhD, MS
role: PRINCIPAL_INVESTIGATOR
References: