louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00113048: Subcutaneously Administered CAMPATH in CD52 Expressing Hematologic Malignancies
Official title: A Phase I Study of Subcutaneously Administered CAMPATH in CD52 Expressing Hematologic Malignancies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Hematologic Malignancies
Keywords: CD52 Expressing Hematologic Malignancies
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-06-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This phase I study will involve escalating doses of CAMPATH until the goal dose for the cohort is tolerated. The CAMPATH goal dose will be administered to the patient subcutaneously (SQ) 3 times per week for up to 12 weeks.


Eligibility criteria: Inclusion Criteria:

* Patients with relapsed or refractory hematologic malignancy. The anticipated patient population are patients with chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma or myeloma
* Patients with a history of a hematologic malignancy that has previously been shown by flow cytometry or immunophenotyping analysis to express CD52
* Any chemotherapy, major surgery or irradiation must have been completed at least four (4) weeks before enrollment in this study (6 weeks for mitomycin-C or nitrosourea)
* Patients have recovered from the acute side effects due to prior therapy
* Life expectancy of \> 3 months
* World Health Organization (WHO) Performance Status 0-2
* 18 years of age or older
* Adequate organ function as defined in the protocol

Exclusion Criteria:

* Prior therapy with CAMPATH
* Use of an investigational agent within two (2) weeks prior to study enrollment
* History of anaphylaxis following exposure to humanized monoclonal antibodies
* Known human immunodeficiency virus (HIV) positive
* Prior autologous bone marrow or stem cell transplant if within six (6) months of study entry
* A history or prior allogenic bone marrow transplant or organ transplant
* Known, symptomatic central nervous system (CNS) involvement with lymphoma
* Pregnant or lactating women
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (excluding skin infection, lower urinary tract infection, or oral infection), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Duluth
country: United States
state: Minnesota
city: Durham
country: United States
state: North Carolina
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02144948: Investigation of the Effect of E.-Coli-Nissle as Supporting Therapy to Standard Care of Diabetes Mellitus Type II
Official title: Pilot Study to Investigate the Effect of E-coli-nissle as Probiotic Adjuvant to Antidiabetic Standard Care in Patients With Diabetes Mellitus Type II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus Type II
Keywords: diabetes
Lead sponsor: GWT-TUD GmbH
Sponsor class: OTHER
Collaborators: name: Ardeypharm GmbH
First posted: 2014-05-22
Enrollment: 10
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a pilot study to investigate the effect of e.-coli-nissle as supporting therapy to antidiabetic standard care in patients with diabetes mellitus type II


Eligibility criteria: Inclusion Criteria:

* diabetes mellitus type 2;
* HbA1c \>7 % (stable für 6 months, max. variation of 0,5%)
* stable oral antidiabetic therapy for 6 months with Metformin, Vildagliptin, Gliniden or without oral Antidiabetics
* age of 45 to \<80 years (men and women)

Exclusion Criteria:

* Myocardial infarction or stroke within the last 5 years
* Therapy with acarbose
* Acute peripheral arterial disease within the last 12 months
* Instable metabolic situation
* Uncontrolled hypertension
* Body-Mass-Index ≥ 35 kg/m²
* Smokers
* Daily consumption of probiotic food
* Malignant disease within the last 5 years
* Status post transplantation
* Immunosuppressive therapy within the last 3 months
* Therapy with antibiotics
* Macroalbuminuria
* Severe liver disease

Primary outcomes:
measure: Decrease in HbA1c levels
timeFrame: 24 weeks
Secondary outcomes:
measure: change in insulin resistance/secretion
timeFrame: 24 weeks
measure: change in lipid parameters
timeFrame: 24 weeks
measure: change in parameters of oxidative stress
timeFrame: 24 weeks
measure: change in gastrointestinal condition
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Carus-Hausarztpraxis
Study officials:
affiliation: Carus Hausarztpraxis on behalf of GWT-TUD GmbH
name: Antje Bergmann, Prof.Dr.med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitätsklinikum Dresden on behalf of GWT-TUD GmbH
name: Stefan R. Bornstein, Prof.Dr.med
role: STUDY_CHAIR
References:
Clinical trial NCT03259048: Role of Ultrasound in Diagnosis of Acute Abdomen in Pediatric Group
Official title: Role of Ultrasound in Diagnosis of Acute Abdomen in Pediatric Group
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ultra Sound in Diagnosis of Acute Abdomen in Pediatric Group
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-08-23
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients referred from the emergency Pediatric Unit for the assessment of the cause of acute abdomen from age of 1 day to 18 years.

Brief summary: Acute abdomen can be defined as "A syndrome induced by wide variety of pathological conditions that require emergent medical or more often surgical management" \[1\].There are a plethora of causes that can lead to acute abdomen in children, they vary depending on the ages of the children and can be divided into diseases that can be treated with medical care and those in which emergency surgical intervention must be considered \[2\]. Ultrasonography is the initial choice in the diagnosis of the different causes of acute abdomen in children \[3, 4\]. It is very useful as it is non-invasive, cost- effective, repetitive, with no radiation exposure, as good as laparoscopy, can be done even in patients with scarred abdomen \[5\].

Detailed description: -Patient preparation:

* No specific preparation is needed.
* Demographic data including age, sex, detailed history, clinical presentation, laboratory tests, and data of any other investigations or operation will be obtained.
* Clinical examination will be done in emergency pediatric unit for provisional diagnosis.

  -Study instruments:• Patients will examined by Grey-Scale Ultrasonography (U/S) combined with Color Doppler Ultrasonography (CDUS).

  3-Technique of examination
* will be in supine position.
* Patient First examination of whole abdomen will be done by Grey -Scale U/S using both 3.5 MHZ and 7.5 MHZ transducers .It will be done in both longitudinal ( parallel to long axis of the patient ) and transverse ( perpendicular to long axis of the patient ) orientation .
* Then finally examination by Color Doppler US will be done for assessment of organ perfusion and diagnosing inflammation.

Eligibility criteria: Inclusion Criteria:

* -In this study, 100 patients referred from the emergency Pediatric Unit for the assessment of the cause of acute abdomen.

Exclusion Criteria:

* - Patients of age group above 18 years
* Patients with trauma.

Primary outcomes:
measure: efficacy of ultrasound in diagnosis of acute abdomen
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00527748: Foot and Ankle Range of Motion (Stretching) Apparatus
Official title: The Use of a New Foot and Ankle Range of Motion (Stretching) Apparatus in Subjects With Stiff Ankles
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Plantar Fasciitis
Flatfoot
Calcaneus Fractures
Keywords: Range of Motion
Ankle Fractures
Elderly patients
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2007-09-11
Enrollment: 26
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: Range of motion at ankle joint and subtalar joint will be assessed before and after utilization of ARM device. The changes in range of motion will be recorded and compared to literature.

Detailed description: The purpose of this study is to assess how effective a new device is in increasing range of motion and reducing stiffness in the foot and ankle of patients with acquired flatfoot, patients with plantar fasciitis, and those suffering from stiffness after cast removal or other lengthy immobilization.

Project will utilize a physical therapist to measure range of motion and stiffness when patients are consented. Patients will be re-measured at six weeks following use of the device to assist in stretching ankle and foot muscles, and again at 10 weeks for final stiffness and range of motion assessment.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* stiffness in or about the ankle joint due to age, diabetes, trauma, flatfoot, plantar fasciitis, or immobilization

Exclusion Criteria:

* not physically able to use device
* patients with pain disorders
* patients lacking necessary hand-eye coordination
* patients using lower extremity external fixator
* patients with history of non-compliance

Primary outcomes:
measure: Change in Range of Motion
timeFrame: Ten weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri-Columbia Healthcare
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia School of Medicine
name: Saul G Trevino, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00696748: The Effect of IM Testosterone Undecanoate on Biochemical and Anthropometric Characteristics of Metabolic Syndrome in Hypogonadal Men
Official title: A Randomized, Placebo-Controlled, Double-Blind, Parallel Group Study With Open-Label Follow-up to Investigate the Effect of IM Testosterone Undecanoate on Biochemical and Anthropometric Characteristics of Metabolic Syndrome in Hypogonadal Men
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Metabolic Syndrome
Hypogonadism
Keywords: metabolic syndrome
hypogonadism
testosterone undecanoate
Lead sponsor: Russian Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2008-06-13
Enrollment: 250
Sex: MALE
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study is to assess the effect of the testosterone therapy on the body composition, lipid and glucose metabolism, inflammatory markers in patients with metabolic syndrome and hypogonadism.


Eligibility criteria: Inclusion Criteria:

* A signed informed consent to participate in the study
* Men aged 35 to 70 with testosterone levels below 12 nmol/L or free testosterone below 225 pmol/L
* Presence of the metabolic syndrome according to the IDF definition

Exclusion Criteria:

* Patients under 35 or above 70 years.
* Participation in any clinical study within 30 days before the first injection of the drug
* Simultaneous participation in another clinical study
* Incapable subjects as well as prisoners
* Suspicion of a serious organic or mental disease according to medical history and/or clinical examination
* Prostate cancer, breast cancer or suspicion thereof
* Presence or history of hepatic tumors
* Acute or chronic hepatic disease
* Presence of renal diseases with renal failure
* Changes in biochemical or hematological laboratory values in spite of lack of clinical manifestations, in the investigator's opinion
* Suspected lack of the patient's compliance
* Hypersensitivity to the active substance

Primary outcomes:
measure: waist-to-hip ratio
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Scientific Centre for Endocrinology RAMS
Study officials:
affiliation: Scientific Center for Endocrinology, Russia
name: Svetlana Kalinchenko, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kalinchenko SY, Tishova YA, Mskhalaya GJ, Gooren LJ, Giltay EJ, Saad F. Effects of testosterone supplementation on markers of the metabolic syndrome and inflammation in hypogonadal men with the metabolic syndrome: the double-blinded placebo-controlled Moscow study. Clin Endocrinol (Oxf). 2010 Nov;73(5):602-12. doi: 10.1111/j.1365-2265.2010.03845.x.
citation: Giltay EJ, Tishova YA, Mskhalaya GJ, Gooren LJ, Saad F, Kalinchenko SY. Effects of testosterone supplementation on depressive symptoms and sexual dysfunction in hypogonadal men with the metabolic syndrome. J Sex Med. 2010 Jul;7(7):2572-82. doi: 10.1111/j.1743-6109.2010.01859.x. Epub 2010 May 26.
Clinical trial NCT04946448: COmbinAtion Therapy of dieT With biologicalS for Crohn's Disease: the OATS Study
Official title: COmbinAtion Therapy of dieT With biologicalS for Crohn's Disease: the OATS Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Crohn Disease
Inflammatory Bowel Diseases
Diet, Healthy
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2021-06-30
Enrollment: 144
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: This study is a randomised open label study, comparing the FIT diet with standard diet in patients with Crohn's disease treated with biologic therapy.


Eligibility criteria: Inclusion Criteria:

* Adult patients (18-80 years)
* active inflammation of terminal ileum and/or colon with a Simple Endoscopic Score for Crohn's Disease (SES-CD) greater than 5 (or greater than 3 for patients with isolated ileitis),
* patient reported outcome 2 (PRO2 - 7 day average daily stool frequency x 2 + 7 day average daily abdominal pain score x 5) \> 8,
* faecal calprotectin above 250 µg/g.

Exclusion Criteria:

* Abcess,
* Bowel resection within 6 months before enrolment,
* Ostomy,
* Short-bowel syndrome,
* Clinically significant stricture that could require surgery,
* Pregnant,
* Lactating woman or desire to become pregnant during the study,
* Unwilling or unable to follow the study diet.

Primary outcomes:
measure: Steroid-free clinical and biochemical remission
timeFrame: Month 6
Secondary outcomes:
measure: Clinical response
timeFrame: 6 months and 1 year
measure: Clinical remission
timeFrame: 6 months and 1 year
measure: Steroid-free clinical remission
timeFrame: 6 months and 1 year
measure: Endoscopic remission
timeFrame: 1 year
measure: Endoscopic improvement
timeFrame: 1 year
measure: CRP improvement
timeFrame: 6 months and 1 year
measure: Fecal calprotectin improvement
timeFrame: 6 months and 1 year
measure: Number of participants without nutritional deficiencies
timeFrame: 6 months and 1 year
measure: Fatigue
timeFrame: 6 months and 1 year
measure: Health-related quality of life
timeFrame: 6 months and 1 year
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital of Leuven
Study officials:
affiliation: UZ Leuven
name: João PG Sabino, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05903248: Validity and Reliability of the Upper Extremity Star Balance Test in Amateur League American Football Players
Official title: Validity and Reliability of the Upper Extremity Star Balance Test in Amateur League American Football Players
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Athletic Injuries
Keywords: balance
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Bahcehir University Amateur Football Team players will participate in the study.

Brief summary: American football is a team activity that calls for many difficult qualities, including speed, endurance, speed, strength, and quickness. It is getting more and more popular among professional and amateur players, particularly in our nation.

Detailed description: Balance is defined as maintaining posture and postural continuity throughout a movement, despite a changing environment or condition while the body is in motion.

However, the upper extremity star balancing test offers information on only three access elements and the possible dangers may not be thoroughly assessed. As a more thorough upper extremity dynamic balance test, the upper extremity star balance test can provide data in eight directions of physicians and physiotherapists and coaches.

Eligibility criteria: Inclusion Criteria:

* Male individuals between the ages of 18-25
* Being an American football player
* Regular attendance at training sessions

Exclusion Criteria:

* Known neurological disorder
* Serious orthopedic disorders that prevent exercise
* cognitive impairment

Primary outcomes:
measure: Star Excursion Balance Test
timeFrame: one day
measure: Sitting Medicine Ball Throwing
timeFrame: one day
measure: Push Up Test.
timeFrame: one day
measure: Closed Kinetic Chain Upper Extremity Stability Test (TEST)
timeFrame: one day
measure: Upper extremity Y Test
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Xu HR, Zhang YH, Mao Y, Ngo TL, Zhang Q, He G, Feng Z, Sun W, Wang XQ. Validity and reliability of upper extremity star excursion balance test in adolescent swimmers. J Exerc Sci Fit. 2023 Apr;21(2):210-217. doi: 10.1016/j.jesf.2023.02.003. Epub 2023 Feb 27.
Clinical trial NCT03485248: People Living With HIV/AIDS, Nitrate, Endotelial Function, Arterial Stiffness and Skeletal Muscle Oxygenation
Official title: Effect of Ingestion of Beet Juice on Endothelial Function, Arterial Stiffness and Muscle Oxygenation Parameters in People Living With HIV / AIDS Using Antiretroviral Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Keywords: HIV/AIDS
Arterial stiffness
Flow mediated-dilatation
Muscle oxygenation parameters
Microcirculation
Dietary Nitrate
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
First posted: 2018-04-02
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Administration of antiretroviral therapy has brought benefits for infective human immunodeficiency virus-1 (HIV-1)-patients, reducing the number of AIDS-related morbidity and mortality. However, it is responsible for intensifying complications triggered by the chronic inflammatory state associated with virus infection, such as cardiovascular diseases. The current study evaluated effects of single dose (140mL) of Beetroot Juice (BJ) on macro and microvascular endothelial function in HIV-1-patients undergoing antiretroviral terapy, once BJ was shown to be effective in improving these physiological parameters in uninfected individuals.


Eligibility criteria: Inclusion Criteria:

* HIV infection for a period of 1 year or greater
* Regular use of high-potency antiretroviral therapy for at least one year

Exclusion Criteria:

* Individuals who are physically active
* Individuals who are allergic to some component of beet
* Individuals who use nutritional and / or pharmacological ergogenics
* Individuals receiving antibiotics or who have osteomioarticular problems

Primary outcomes:
measure: Skeletal Muscle Oxygenation
timeFrame: Baseline and approximately after 150 minutes of beetroot juice consumption
measure: Brachial artery flow-mediated dilatation
timeFrame: Baseline and approximately after 150 minutes of beetroot juice consumption
Secondary outcomes:
measure: Urinary nitrate concentrations
timeFrame: Baseline and approximately 30, 90, and 150 minutes after beetroot juice consumption
Other outcomes:
Locations:
city: Macaé
country: Brazil
facility: DST / AIDS and Viral Hepatitis Program of Macaé
state: Rio De Janeiro
Study officials:
References:
Clinical trial NCT01537848: Retrospective Study of Endoscopic Ultrasound (EUS) Guided Transmural Drainage of Post-operative Abdominal Collections
Official title: Retrospective Study of Endoscopic Ultrasound Guided Transmural Drainage of Post-operative Collections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-surgical Intra-abdominal Collection
Keywords: EUS
Endoscopic ultrasound
abdominal collection
post-operative
post-surgical
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2012-02-23
Enrollment: 43
Sex: ALL
Minimum age (years): 15
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who underwent EUS guided drainage of post-operative collections admitted between january 2002 and july 2011 for this treatment in the endoscopic department of a single academic center will be included for analysis.

Brief summary: This is a retrospective study of a single center on endoscopic ultrasound (EUS) guided transmural drainage of post-operative collections during a 9 years period.

Detailed description: All patients who underwent a EUS guided drainage of post-operative collection between 2002 and 2011 in the endoscopy unit of Erasme hospital will be included for analysis. The study will focus on retrospective analysis of prospectively collected data. The technique is the same as the one used for pancreatic pseudocysts drainage. The technical success is defined as the ability to access and drain the collection by placement of transmural drain and/or stents. Treatment success (regression of collection) is defined as the resolution of the collection as shown on abdominal imaging (CT or MRI) in association with clinical resolution of symptoms at 8 weeks of follow-up.

Eligibility criteria: Inclusion Criteria:

* All patients who underwent EUS guided drainage of post-operative collections admitted between january 2002 and july 2011 for this treatment in the endoscopic department of a single academic center will be included for analysis.

Exclusion Criteria:

* none (patients for whom other modalities of fluid drainage failed were also included in the study

Primary outcomes:
measure: Treatment success
timeFrame: 8 weeks after treatment
Secondary outcomes:
measure: technical success
timeFrame: day of procedure (day 1)
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Erasme Hospital, Gastroenterology Department, ULB (Université libre de Bruxelles)
Study officials:
affiliation: Erasme Hospital, ULB (Université Libre de Bruxelles), Belgium
name: Jacques Devière, MD,PhD
role: STUDY_CHAIR
References: