louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00006394: Randomized Study of Growth Hormone on Bone Mineral Density in Patients With Adult Onset Growth Hormone Deficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Growth Hormone Deficiency
Keywords: disease-related problem/condition
endocrine disorders
growth hormone deficiency
osteoporosis
quality of life
rare disease
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: University of Pennsylvania
First posted: 2000-10-05
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Compare whether the bone tissue in the spine and hip improves in patients with adult onset growth hormone deficiency treated with growth hormone (GH) vs placebo.

II. Determine whether the blood samples of these patients show evidence of beneficial bone effects after treatment with GH.

III. Compare the quality of life of these patients treated with these 2 regimens.

IV. Determine the side effects of GH in these patients.

Detailed description: PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive growth hormone subcutaneously (SC) daily for 2 years. Arm II: Patients receive placebo SC daily for 2 years. Quality of life is assessed at the initial eligibility screening, then again within 1 month after the initial screening, and then at 1, 3, and 6 months during study therapy.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Diagnosis of adult onset growth hormone deficiency

--Patient Characteristics--

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: St. Louis University Health Sciences Center
state: Missouri
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania School of Medicine
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: University of Pennsylvania
name: Peter Snyder
role: STUDY_CHAIR
References:
Clinical trial NCT05188794: Comparison of Two Different Approach TAP Block on Pain Management of Laparoscopic Nephrectomy
Official title: Comparison of Two Different Approach Ultrasound Guided TAP Block on Pain Management of Laparoscopic Nephrectomy: Posterior or Lateral Approach?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia, Patient-Controlled
Postoperative Pain, Acute
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Primary aim is to compare the effectiveness of the posterior approach Transversus abdominis plane block (P-TAP) and the lateral approach Transversus abdominis plane block (L-TAP) technique on the pain management of the laparoscopic nephrectomy in terms of visual analog pain scale and postoperative opioid consumption. Secondary aim is to compare complication rates of the two techniques.

Detailed description: Patients included in the study will be randomized into two groups (group L and group P) in the preoperative period. Following routine anesthesia induction TAP block will be applied to group L patients with the lateral approach technique, and to group P patients with the posterior approach technique. Regional block complications will be recorded.

Standard laparoscopic nephrectomy surgical method will be applied. 1g of paracetamol and 4mg of dansetron will be administered to both groups 15 minutes before the end of the operation. The pain intensity of the patients will be questioned and VAS values will be recorded at 0, 1, 2, 6, 12 and 24 hours postoperatively.

Eligibility criteria: Inclusion Criteria:

* ASAI-III patients undergoing laparoscopic nephrectomy
* 18\<BMI\<40

Exclusion Criteria:

* infection at the block site
* coagulation disorder
* pregnancy
* kidney failure
* liver failure
* heart failure
* allergy to local anesthetics
* patient refusal

Primary outcomes:
measure: Visual analog pain scale 0
timeFrame: at the PACU arrival
measure: Visual analog pain scale 1
timeFrame: Postoperative first hour
measure: Visual Analog Pain scale 2
timeFrame: Postoperative second hour
measure: Visual analog pain scale 6
timeFrame: Postoperative sixth hour
measure: Visual Analog Pain scale 12
timeFrame: Postoperative 12. hour
measure: Visual Analog Pain scale 18
timeFrame: Postoperative18. hour
measure: Visual Analog Pain scale 24
timeFrame: Postoperative 24. hour
measure: opioid comsuption
timeFrame: Within 24 hours postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital,Bilkent
state: Cankay
Study officials:
affiliation: ANKARA CİTY HOSPİTAL
name: MİYASE SERAP DİKER, DOCTOR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06505694: A Clinical Trial to Assess the Impact of an Alcohol Alternative Herbal Tincture on Signs of Stress Anxiety and Sleep Quality.
Official title: A Clinical Trial to Assess the Impact of an Alcohol Alternative Herbal Tincture on Signs of Stress Anxiety and Sleep Quality.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Stress
Keywords: Sleep Quality
Sleep Tracker
Relaxation
Herbal Tincture
Lead sponsor: Apothekary
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2024-07-17
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: This is a virtual randomized placebo-controlled double-blind trial lasting eight weeks. The trial will assess the effects of a test product on improving sleep quality, promoting a sense of calm, and reducing feelings of stress and anxiety, using a sleep tracker and subject-specific questionnaires. The study involves 80 participants who experience sleep issues and feelings associated with stress and anxiety.


Eligibility criteria: Inclusion Criteria:

* Aged 21-65 years
* Male or female
* Good general health
* Experience daily feelings of stress and anxiety within the past two weeks
* Experience daily problems with sleeping, reduced energy levels, and fatigue over the past two weeks
* Have used alcohol products to help relax or sleep within the past two weeks
* Experience tension in the body within the past two weeks
* Experience problems with relaxing in the evening within the past two weeks
* Willing to abstain from alcohol for the duration of the study
* Willing to maintain stable use of other herbal supplements, over-the-counter medications, or prescriptions during the study

Exclusion Criteria:

* Chronic health conditions, including oncological and psychiatric disorders
* Taking SSRIs, sedative, or blood pressure-lowering medications
* Pregnant, breastfeeding, or planning to conceive within the next three months
* Currently enrolled or planning to enroll in another research trial over the next eight weeks
* History of substance abuse
* Known serious allergic reactions requiring an Epi-Pen

Primary outcomes:
measure: Improvements in Sleep Quality and Mental Well-Being
timeFrame: Baseline, Week 2, Week 4, Week 6, and Week 8
Secondary outcomes:
measure: Changes in Sleep Length and Quality
timeFrame: Baseline, Week 4, and Week 8
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References:
Clinical trial NCT01789294: Clinical Management of Childhood Intestinal Lymphoid Nodular Hyperplasia
Official title: CLINICAL MANAGEMENT OF CHILDHOOD INTESTINAL LYMPHOID NODULAR HYPERPLASIA: A RANDOMIZED CONTROLLED CLINICAL TRIAL.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Intestinal LNH
Keywords: lymphoid nodular hyperplasia
food allergy
Lead sponsor: Azienda Policlinico Umberto I
Sponsor class: OTHER
First posted: 2013-02-12
Enrollment: 270
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Aim of this prospective, parallel multi-arm, randomized, clinical trial, was to compare the clinical outcome of patients Methods.We recruited children who undergone diagnostic colonoscopy in Umberto I Pediatric Department (Rome, Italy) from 2008 to 2010. Eligibility criteria were: 1) only demonstration of LNH; 2) no concomitant disease; 3) no treatment assumed since the clinical onset. Patients were allocated 1:1:1 to dietetic (Group A) vs mesalamine (Group B) vs no treatment (Group C) for a 8-weeks period. Skin prick tests and patch test for common foods, and symptoms scoring at baseline and follow up have been performed by blinded clinicians. Chi-square test for trend was used to compare the frequency of symptoms score improvement (\>1 point) among groups. The association of baseline features of patients with the clinical response was estimated by frequency analysis.

Detailed description: Lymphoid nodular hyperplasia (LNH) of the lower gastrointestinal tract is a common finding in pediatric colonoscopies, whose clinical significance is not yet been clearly established. Although initially considered to be a normal, age-related variant, some authors recently suggested to regard LNH as a marker of food allergy (FA).

Eligibility criteria: Inclusion Criteria:

1. isolated finding of LNH\[18\], defined as the demonstration of a significant cluster of lymphoid nodules (\>10/visible field) by endoscopy and lymphoid follicle hyperplasia by hystology;
2. negative results of preliminary evaluation

Exclusion Criteria:

1. diagnosis of concomitant inflammatory, rheumatic or infectious disease, and
2. the assumption of any dietetic or therapy since the clinical onset.

Primary outcomes:
measure: Efficacy
timeFrame: 8 weeks
Secondary outcomes:
measure: predictive factors
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Departments of Pediatrics, Sapienza - University of Rome
Study officials:
References:
Clinical trial NCT02564094: A Study of Epoetin Beta (NeoRecormon) in Participants With Solid Tumors or Hematologic Malignancies
Official title: Optimizing Treatment of the Anaemia in Onco-Hematological Diseases With NeoRecormon 30,000 IU Once Weekly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-09-30
Enrollment: 54
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 study will evaluate the efficacy, safety, and pharmacoeconomics of treatment with subcutaneous (SC) epoetin beta (NeoRecormon) in participants with hematologic malignancies or solid tumors. The anticipated time on study treatment is 20 weeks, and the target sample size is 60 individuals.


Eligibility criteria: Inclusion Criteria:

* Adults at least 18 years of age
* Multiple myeloma (MM), low-grade non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), breast cancer, lung cancer, or ovarian cancer
* Anemia with low erythropoeitin (EPO) levels

Exclusion Criteria:

* Poorly controlled hypertension
* Relevant acute or chronic bleeding requiring therapy within 3 months before study drug
* Treatment with EPO within the last 6 weeks
* Pregnant or breastfeeding females

Primary outcomes:
measure: Response rate according to hemoglobin level
timeFrame: At Week 4
measure: Transfusion requirement rate
timeFrame: From Weeks 5 to 12
measure: Predictive value of reticulocyte increase
timeFrame: At Week 2
Secondary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: Up to approximately 6 months
Other outcomes:
Locations:
city: Plovdiv
country: Bulgaria
city: Plovdiv
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Stara Zagora
country: Bulgaria
city: Varna
country: Bulgaria
city: Varna
country: Bulgaria
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References:
Clinical trial NCT01699594: Change in Airway Responsiveness After Allergen Exposure
Official title: Allergen Induced Increase in Indirect Non-allergic Bronchial Reactivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergic Asthma
Keywords: asthma
allergies
mannitol
methacholine
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2012-10-03
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Exposure to allergens changes the way the airway responds to some stimuli (methacholine). The investigators will look at whether or not exposure to allergens changes the way the airway responds to a different stimuli (mannitol) and compare that with the known stimuli (methacholine).


Eligibility criteria: Inclusion Criteria:

* mild, allergic asthma
* FEV1 greater than 70% predicted
* methacholine PC20 less than or equal to 16mg/ml

Exclusion Criteria:

* known sensitivity to mannitol or other excipient
* diagnosis of any other respiratory or non respiratory disease/disorder that would preclude the individual from participating
* recent thoracic, abdominal or eye surgery
* recent allergen exposure (4 weeks), respiratory infection (6 weeks)
* current immunotherapy
* pregnancy
* history of anaphylaxis
* use of asthma therapies other than short acting beta agonist

Primary outcomes:
measure: Change from baseline in airway responsiveness three hours after allergen exposure
timeFrame: Change from Baseline at 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Donald W Cockcroft, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Amakye DO, Davis BE, Martin AL, Peters GE, Cockcroft DW. Refractoriness to inhaled mannitol 3 hours after allergen challenge. Ann Allergy Asthma Immunol. 2013 Sep;111(3):182-4. doi: 10.1016/j.anai.2013.06.011. Epub 2013 Jul 12.
Clinical trial NCT00464594: Japan Early Diabetes Intervention Study
Official title: A Randomized Comparative Clinical Study on Suppression of Progression From Early Diabetes, Diet/Exercise Standard Intervention vs. Concurrent Pharmacological Standard Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Japan Early Diabetes Intervention Study
Lead sponsor: Japan Early Diabetes Intervention Study Group
Sponsor class: OTHER
First posted: 2007-04-23
Enrollment: 2560
Sex: ALL
Minimum age (years): 30
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the suppressive effect of two kinds of interventions on the worsening/progression to definite diabetes: standard lifestyle guidance and standard lifestyle guidance combined with pharmacological intervention (monotherapy with one of acarbose, metformin, or gliclazide).

Detailed description: In newly-diagnosed early diabetes patients, a randomized comparative study will be conducted to compare the suppressive effect of the following two kinds of interventions on the worsening/progression to definite diabetes which has a harmful hyperglycemia i.e. an increased risk of microangiopathy: standard education for the improvement of lifestyle in accordance with the "Guidelines for the Treatment of Diabetes Mellitus in Japan" of the Japan Diabetes Society (JDS) and standard lifestyle guidance combined with pharmacological intervention using the lowest possible dose of commercially available oral hypoglycemic agents (one of acarbose, metformin, or gliclazide) in Japan.

Eligibility criteria: Inclusion Criteria:

* Results of 75-g oral glucose tolerance test (75 g OGTT)will be used to confirm FPG \<= 125 mg/dL, 2-h PG \>= 200 mg/dL and HbA1c \<= 6.9%

Exclusion Criteria:

* Type 1 diabetes mellitus
* Undergoing treatment with steroids
* Secondary diabetes mellitus
* Diabetes mellitus due to suspected gene abnormalities
* BMI \>= 35 kg/m2 or BMI \< 18.5 kg/m2
* Undergone a surgery
* Severe hyperuricemia (gout) associated with organ dysfunction
* Severe vascular diseases with organ dysfunction
* Cancer or other malignant neoplasms
* Liver cirrhosis or chronic hepatic, chronic renal failure
* Gastrointestinal disorders
* Always performing rigorous muscular exercise
* Severe infection or serious trauma
* Women who are pregnant
* Alcohol dependence or drug dependence
* Drug allergy
* Anemic
* Abnormal hemoglobinuria
* Severe mental disease

Primary outcomes:
measure: FPG >= 140mg/dl and HbA1c >= 7.0%
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Tokyo Medical and Dental University
Study officials:
affiliation: Jichi Medical University
name: Takeshi Kuzuya
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02934594: Metastatic Spinal Cord Compression (MSCC): Treatment Timing and Survival Rate
Official title: Metastatic Spinal Cord Compression (MSCC): Treatment Timing and Survival Rate
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neoplasm Metastasis
Spinal Cord Compression
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2016-10-17
Enrollment: 500
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with metastatic spinal cord compression (MSCC) who underwent palliative decompression.

Brief summary: Patients with metastatic spinal cord compression (MSCC) are treated with different options according to the life expectancy. Survival and surgical outcome can be influenced by surgical timing in MSCC patients treated with palliative decompression.

Detailed description: MSCC patients who underwent palliative decompression after January 2012 in National Taiwan University Hospital (NTUH) were divided into the preoperative motor function intact group (Group A) and motor deficit group (Group B). The motor deficit group was subdivided into operation within 48 hours (Group B1), and after 48 hours (Group B2). All patients underwent palliative decompression and posterior stabilization. Investigators did wide laminectomy for tumor invading the vertebral body, and debulking surgery for tumor destructing the posterior column of the spine. Investigators retrospectively reviewed all patient records, including patient demographics, prognostic factors for survival (Kaplan-Meier survival analysis), neurological outcome (Frankel grade), primary tumor, complications, and relevance of Tomita and Tokuhashi scores.

Eligibility criteria: Inclusion Criteria:

* Patients with metastatic spinal cord compression (MSCC) who underwent palliative decompression in National Taiwan University Hospital after January 1st, 2012.

Exclusion Criteria:

* Patients with metastatic spinal cord compression (MSCC) who underwent palliative decompression before December 31st, 2011, or those who were not treated in National Taiwan University Hospital.

Primary outcomes:
measure: survival rate
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Taiwan University Hospital
name: Shu-Hua Yang, M.D., Ph.D.
role: STUDY_CHAIR
References:
citation: Tokuhashi Y, Matsuzaki H, Oda H, Oshima M, Ryu J. A revised scoring system for preoperative evaluation of metastatic spine tumor prognosis. Spine (Phila Pa 1976). 2005 Oct 1;30(19):2186-91. doi: 10.1097/01.brs.0000180401.06919.a5.
citation: Tomita K, Kawahara N, Kobayashi T, Yoshida A, Murakami H, Akamaru T. Surgical strategy for spinal metastases. Spine (Phila Pa 1976). 2001 Feb 1;26(3):298-306. doi: 10.1097/00007632-200102010-00016.
Clinical trial NCT02063594: Single Dose Safety, Tolerability and Pharmacokinetic Study of NCTX in Healthy Volunteers
Official title: Phase 1 Single Dose, Double-blind, Dose-escalation, Safety, Tolerability and Pharmacokinetic Study of NCTX (PEGylated Liposomal Iodixanol Injection) in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Iodixanol
Iodinated Contrast
Liposome
Computed Tomography
X-ray Imaging
Blood pool agent
Biomarker
Lead sponsor: Marval Pharma Ltd.
Sponsor class: INDUSTRY
First posted: 2014-02-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This is a randomized, double-blind, single dose, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics of NCTX (PEGylated Liposomal Iodixanol Injection) administered intravenously to healthy volunteers. In addition, computed tomography (CT) scans will be acquired to measure radiographic density in regions of interest (ROI) at times from 3-5 hours and up to 72 hours following NCTX administration.


Eligibility criteria: Inclusion Criteria:

* Healthy, nonsmoking men and women 18 to 55 years of age
* Body Mass Index (BMI) between 18.5 and 30.0 kg/m2
* Serum creatinine within normal range and calculated creatinine clearance of 80 mL/min/1.73 m2 or greater

Exclusion Criteria:

* Concurrent enrollment in another clinical trial or treatment with any investigational products or therapies within 30 days prior to dosing
* History of infusion reactions to liposomes, nanoparticles, monoclonal antibodies, or intravenously administered materials
* History of allergic/anaphylactoid-like reactions attributed to iodinated contrast agents or other components of the formulation
* Disturbances in normal fat metabolism, or total cholesterol greater than 240 mg/dL
* Pregnant or nursing women
* Exposure to significant radiation within 1 year, or previous CT scan within 5 years prior to check-in

Primary outcomes:
measure: Assessment of safety by clinical laboratory parameters, vital sign measurements, electrocardiograms, and adverse event monitoring
timeFrame: Baseline and up to and including 28 days post drug administration
Secondary outcomes:
measure: Maximum blood concentration (Cmax), half-life (t1/2), and ratio of free to encapsulated circulating iodixanol
timeFrame: Baseline and up to 28 days post drug administration
measure: Radiographic density in ROIs by abdominal CT imaging
timeFrame: From 3-5 hours and up to 72 hours following NCTX administration
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Quintiles Phase 1 Services
state: Kansas
Study officials:
affiliation: Quintiles Phase 1 Services
name: Philip T Leese, MD
role: PRINCIPAL_INVESTIGATOR
References: