louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00275236: A Sleep Lab Trial to Investigate the Efficacy and Safety of Transdermal Rotigotine in Subjects With Idiopathic Restless Legs Syndrome
Official title: A Multi-center, Double-blind, Randomized, Placebo-controlled, Two-arm, Parallel-group, Sleep Lab Trial to Investigate the Efficacy and Safety of Transdermal Rotigotine in Subjects With Idiopathic Restless Legs Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Restless Legs Syndrome
Keywords: Idiopthic Restless Legs Syndrome
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2006-01-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this trial is to demonstrate that rotigotine (SPM 936) is effective in subjects with idiopathic RLS based on the PLMI (Periodic Limb Movements Index)(PLMs/total time in bed) as measured by polysomnography (PSG). The primary variable is the reduction of PLMI at the end of the Maintenance Period compared to Baseline. PLMI data will be obtained from PSGs.


Eligibility criteria: Inclusion Criteria:

* Idiopathic RLS

Exclusion Criteria:

* secondary RLS
* history of sleep disturbances
* symptomatic orthostatic hypotension

Primary outcomes:
measure: Efficacy is assessed by reduction of Periodic Limb Movement Index, which will be obtained from polysomnographic measurements.
Secondary outcomes:
measure: Changes in Periodic Limb Movement Arousal Index, Sleep efficiency, International RLS sum score, Clinical Global Impression Item 1.
Other outcomes:
Locations:
city: Monheim
country: Germany
facility: Schwarz BioSciences
Study officials:
affiliation: UCB Pharma
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Oertel WH, Benes H, Garcia-Borreguero D, Hogl B, Poewe W, Montagna P, Ferini-Strambi L, Sixel-Doring F, Trenkwalder C, Partinen M, Saletu B, Polo O, Fichtner A, Schollmayer E, Kohnen R, Cassel W, Penzel T, Stiasny-Kolster K. Rotigotine transdermal patch in moderate to severe idiopathic restless legs syndrome: a randomized, placebo-controlled polysomnographic study. Sleep Med. 2010 Oct;11(9):848-56. doi: 10.1016/j.sleep.2010.02.014. Epub 2010 Sep 1.
Clinical trial NCT00951236: Study Comparing One Versus Two Cortisone Injections for Trigger Finger
Official title: A Prospective, Randomized Study Comparing One vs. Two Cortisone Injections for Trigger Finger
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stenosing Tenosynovitis
Trigger Finger
Keywords: Trigger Finger
Trigger Thumb
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2009-08-04
Enrollment: 392
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Trigger finger, also known as stenosing tenosynovitis, is a painful condition that can cause discomfort and disability. Many physicians choose to locally inject cortisone into the infected finger although there is no current consensus as to how many injections are needed to achieve maximum relief. This study will be a prospective, randomized study to compare one versus two injections for the treatment of trigger finger.


Eligibility criteria: Inclusion Criteria:

* Subject is greater than 18 years of age, presenting with stenosing tenosynovitis.
* Subject is willing and able to provide informed consent.

Exclusion Criteria:

* Patients who have previously undergone surgery for the treatment of trigger finger.

Primary outcomes:
measure: To determine if there is a difference in the incidence of pain, stiffness, clicking or locking at 6 months following final injection
Secondary outcomes:
measure: To evaluate treatment response among diabetic patients
measure: To evaluate treatment response between thumbs and fingers
measure: To evaluate treatment response between nodular versus diffuse tenosynovitis
Other outcomes:
Locations:
city: Egg Harbor Township
country: United States
facility: Rothman Institute: Egg Harbor Township Location
state: New Jersey
city: Manahawkin
country: United States
facility: Rothman Institute: Manahawkin location
state: New Jersey
city: Vorhees
country: United States
facility: Rothman Institute: Vorhees location
state: New Jersey
city: Media
country: United States
facility: Rothman Institute: Media location
state: Pennsylvania
city: Philadelphia
country: United States
facility: Rothman Institute Center City Location
state: Pennsylvania
city: Philadelphia
country: United States
facility: Rothman Institute, South Philadelphia Location
state: Pennsylvania
city: Philadelphia
country: United States
facility: Rothman Institute, Northeast Philadelphia location
state: Pennsylvania
Study officials:
affiliation: Rothman Institute
name: Charles Leinberry, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rothman Institute
name: Pedro Beredjiklian, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rothman Institute
name: Emran Sheikh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00403936: Effects of OA Decompression on the Autonomic Nervous System
Official title: Effects of OA Decompression on Activity of the Autonomic Nervous System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Tension
Keywords: osteopathic manipulation
autonomic nervous system
Lead sponsor: Nova Southeastern University
Sponsor class: OTHER
First posted: 2006-11-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study was designed to determine whether a simple manipulative technique of relaxing the tissues of the occipito-atlantal junction in the neck had any effect on the activity of the sympathetic or parasympathetic nervous system. Subjects were dark adapted then measures of pupillary activity, reflecting autonomic nervous system activity were taken before and after treatment. The study hypothesis was that thet treatment technique would have no effect on the pupillary measures, hence indicating no effect on autonomic system activity.

Detailed description: This study was a within subjects/crossover design in which each subject received the treatment and served as his/her own control. 100 subjects were recruited from the student/staff population of the university, were 18 y/o or older with no condition affecting pupillary activity. Pupillary activity was measured with a PLR100 pupillometer and included pupillary diameter, pupillary response latency, maximum constriction velocity and maximum redilation velocity. Subjects were adapted to a dim light environment, measures taken, treatment given at either third or fourth time period and measures retaken. The study was approved by the NSU IRB. Subject numbers were sufficient to have statistical power to find an effect. The study found an effect of treatment on maximum size, showing a decrease with treatment.

Eligibility criteria: Inclusion Criteria:

* 18 y/o
* Normal accommodation and pupillary response
* Willing to undergo osteopathic manipulation

Exclusion Criteria:

* Active ocular or systemic disease
* Neurologic disease that would alter pupillary response
* Chronic pain syndromes of head or neck
* Pregnant
* Brain injury
* Taking medications that would alter autonomic tone

Primary outcomes:
measure: pupillary diameter
measure: pupillary latency
measure: pupillary constriction velocity
measure: pupillary redilation velocity
Secondary outcomes:
Other outcomes:
Locations:
city: Ft. Lauderdale
country: United States
facility: College of Osteopathic Med, Nova Southeastern Univ
state: Florida
Study officials:
affiliation: College of Osteo Med, Nova Southeastern Univ
name: Chris Piromalli, MSIII
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00120536: Efficacy and Safety of Three Doses of Vildagliptin in Drug Naive Patients With Type 2 Diabetes
Official title: Efficacy and Safety of Three Doses of Vildagliptin in Drug Naive Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes
vildagliptin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-07-18
Enrollment: 288
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: The purpose of this study is to assess the long term safety and effectiveness of three doses of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar.


Eligibility criteria: Inclusion Criteria:

* Not currently on drug therapy for type 2 diabetes
* Blood glucose criteria must be met
* Body mass index (BMI) in the range 22-45

Exclusion Criteria:

* History of type 1 diabetes
* Evidence of significant diabetic complications
* Serious cardiovascular events within the past 6 months
* Laboratory value abnormalities as defined by the protocol
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Change from baseline in HbA1c at 24 weeks
Secondary outcomes:
measure: Adverse event profile after 24 weeks of treatment
measure: Change from baseline in fasting plasma glucose at 24 weeks
measure: Patients with endpoint HbA1c < 7% after 24 weeks
measure: Patients with reduction in HbA1c >/= 0.7% after 24 weeks
measure: Change from baseline in HbA1c at 24 weeks for patients with high baseline HbA1c vs. low baseline HbA1c
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Pratley RE, Schweizer A, Rosenstock J, Foley JE, Banerji MA, Pi-Sunyer FX, Mills D, Dejager S. Robust improvements in fasting and prandial measures of beta-cell function with vildagliptin in drug-naive patients: analysis of pooled vildagliptin monotherapy database. Diabetes Obes Metab. 2008 Sep;10(10):931-8. doi: 10.1111/j.1463-1326.2007.00835.x. Epub 2007 Dec 17.
citation: Pratley RE, Rosenstock J, Pi-Sunyer FX, Banerji MA, Schweizer A, Couturier A, Dejager S. Management of type 2 diabetes in treatment-naive elderly patients: benefits and risks of vildagliptin monotherapy. Diabetes Care. 2007 Dec;30(12):3017-22. doi: 10.2337/dc07-1188. Epub 2007 Sep 18.
citation: Pi-Sunyer FX, Schweizer A, Mills D, Dejager S. Efficacy and tolerability of vildagliptin monotherapy in drug-naive patients with type 2 diabetes. Diabetes Res Clin Pract. 2007 Apr;76(1):132-8. doi: 10.1016/j.diabres.2006.12.009. Epub 2007 Jan 12.
Clinical trial NCT04883736: A Study Comparing Tretinoin Gel Microsphere, 0.1% and RETIN-A MICRO ® Gel Microsphere, 0.1% in the Treatment of Acne Vulgaris
Official title: A Multi-center, Double-blind, Randomized, Placebo Controlled, Parallel-Group Study Comparing Tretinoin Gel Microsphere, 0.1% (Taro Pharmaceuticals U.S.A, Inc.) to RETIN-A MICRO® (Tretinoin) Gel Microsphere, 0.1% (Valeant) and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Acne Vulgaris
Lead sponsor: Taro Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2021-05-12
Enrollment: 973
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To demonstrate the therapeutic equivalence and safety of Tretinoin Gel Microsphere, 0.1% (Taro Pharmaceuticals U.S.A, Inc.) and RETIN-A MICRO® (Tretinoin) Gel Microsphere, 0.1% (Valeant) in the treatment of acne vulgaris.

Detailed description: A multi-center, double-blind, randomized, placebo controlled, parallel-group study, comparing Tretinoin Gel Microsphere, 0.1% (Taro Pharmaceuticals U.S.A, Inc.) and RETIN-A MICRO® (Tretinoin) Gel Microsphere, 0.1% (Valeant) in the treatment of acne vulgaris.

Eligibility criteria: Inclusion Criteria:

* Healthy male or non pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
* Subjects who are 18 years of age or older (up to the age of 40) must have provided IRB approved written informed consent. Subjects ages 12 to 17 years of age, inclusive, must have provided IRB approved written assent
* Subjects must have a definite clinical diagnosis of acne vulgaris of severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA)

Exclusion Criteria:

* Female Subjects who are pregnant, nursing or planning to become pregnant during study participation
* Subjects with a history of hypersensitivity or allergy to tretinoin, retinoids, or any of the study medication ingredients.
* Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).

Primary outcomes:
measure: The percentage change in the inflammatory and non-inflammatory lesion counts
timeFrame: Baseline to Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Catawba Research, LLC
state: North Carolina
Study officials:
affiliation: Catawba Research
name: Zaidoon A. Al-Zubaidy
role: STUDY_DIRECTOR
References:
Clinical trial NCT05325736: Improvement in Glycemic Response After Bariatric Surgery
Official title: Improvement in Glycemic Response After Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bariatric Surgery
Lead sponsor: Weizmann Institute of Science
Sponsor class: OTHER
Collaborators: name: Tel-Aviv Sourasky Medical Center
First posted: 2022-04-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients arriving at the outpatient unit at Tel Aviv Sourasky medical center

Brief summary: decipher the role of microbiota in glycemic response change after bariatric surgery

Detailed description: Despite the vast knowledge linking the gut microbiome to metabolism and the glucose response, the relation still remains unclear. hopefully, a deep understanding of the mechanisms underlying metabolic improvement following bariatric surgery will make it possible to identify targets for pharmacological intervention, which will reduce the need for surgery and its risks.

Previous studies have characterized the microbiome after bariatric surgery, but most suffer from methodological limitations.

The current study has the potential to be innovative and make a significant contribution to understanding the mechanisms involved in early metabolic improvement after bariatric surgery.

Eligibility criteria: Inclusion Criteria:

* candidates of bariatric surgery or cholecystectomy
* age 18-70
* male/female

Exclusion Criteria:

* previous bariatric surgery
* type 1 diabetes
* antibiotic treatment 3 months prior to the study
* probiotic treatment 3 months prior to the study
* chronic disease - gastrointestinal disease, malignancy, psychiatric disorder, endocrinologic disorders
* any pathologic findings during endoscopy
* participants who will suffer from a post-operation complication

Primary outcomes:
measure: Glycemic response
timeFrame: up to 4 years
measure: microbiota composition
timeFrame: up to 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Reẖovot
country: Israel
facility: Weizmann Institute of Science
city: Tel Aviv
country: Israel
facility: Souraski medical center
Study officials:
affiliation: Weizmann institute
name: Avner Leshem, MD
role: STUDY_DIRECTOR
affiliation: Souraski medical center
name: Danit Dayan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02902536: Tissue Repository for Studies of Myasthenia Gravis
Official title: Tissue Repository for Studies of Myasthenia Gravis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myasthenia Gravis
Keywords: Myasthenia Gravis
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2016-09-15
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Myasthenia Gravis and normal controls

Brief summary: This is a study during which the investigators collect plasma and cells from patients with myasthenia gravis for the purpose of finding new antibodies.

Detailed description: This is a bio-specimen collection study. The investigators will collect plasma and peripheral lymphocytes. Plasma will be collected either when the patient undergoes plasma exchange, a decision independent of this study, or through a scheduled blood draw.

Patient plasma will be screened for novel antibodies which may cause myasthenia gravis. Subjects that are found to be positive for candidate antigens for myasthenia gravis will have a clinical evaluation which will consist of several disease rating scales will be performed (QMG score, MG-composite, Myasthenia Gravis Foundation of America (MGFA) clinical classification, MG-Quality of Life (QOL)15, MGFA Therapy Status).

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older.
* Clinical Diagnosis of MG with supporting evidence either from antibody testing, repetitive nerve stimulations study (RNS) or Single Fiber Electromyography (EMG) (SFEMG).

Exclusion Criteria:

* Significant medical condition that would make participation in diagnostic and research part of evaluation impossible or risky. Acute or unstable medical condition.
* Inability to provide informed consent, either directly or via appointed power of attorney.
* Unwillingness to consent for collection of biological samples or their cryopreservation.
* Unable to provide evidence of previous antibody testing or neurophysiology confirming the diagnosis of Myasthenia Gravis.
* Any bleeding disorder that would prevent or present any danger during blood extraction.

Primary outcomes:
measure: Identification of New Antibodies in Myasthenia Gravis assessed by enzyme-linked immunosorbent assay (ELISA)
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
References:
Clinical trial NCT06694636: Intravascular Radiofrequency Ablation of Sympathetic Nerves for the Treatment of Hepatocellular Carcinoma
Official title: Intravascular Radiofrequency Ablation of Sympathetic Nerves for the Treatment of Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular Carcinoma
Sympathetic Nerves
Intravascular Radiofrequency Ablation
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
First posted: 2024-11-19
Enrollment: 5
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Enrolled patients will receive intravascular Radiofrequency Ablation of Sympathetic Nerves for the Treatment of Hepatocellular Carcinoma
Primary purpose: TREATMENT

Brief summary: Patients who met the inclusion criteria were treated with endovascular radiofrequency ablation and desympathetic nerve surgery. After enrollment, endovascular radiofrequency ablation and desympathetic surgery were performed. After radiofrequency ablation, the safety and efficacy of follow-up treatment will be carried out every 1 month or so, including blood routine, liver and kidney function, tumor indicators, abdominal CT/magnetic resonance, etc.


Eligibility criteria: Inclusion Criteria:

* Clinically or pathologically confirmed hepatocellular carcinoma (HCC)
* Locally progressed or distant metastatic unresectable advanced HCC
* Progressed after second-line therapy
* Agree to participate in the study and sign the informed consent form

Exclusion Criteria:

* Not suitable for ablation surgery
* Pregnant, lactating and planning to become pregnant
* Orthostatic hypotension
* Mixed liver cancer
* Intestinal obstruction
* Obvious bleeding tendencies and hematologic diseases
* Acute or severe systemic infection;
* Stroke or transient ischemic attack (TIA) within two weeks;
* Acute coronary syndrome within two weeks;
* Evaluated to be not suitable for this trial by investigators

Primary outcomes:
measure: ORR
timeFrame: every month, up to 1 year
Secondary outcomes:
measure: PFS
timeFrame: every month, up to 1 year
measure: DCR
timeFrame: every month, up to 1 year
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital
state: Jiangsu
Study officials:
affiliation: Zhongda Hospital
name: Gao-Jun Gao-Jun
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02751736: The Effect Of Probiotics On Bowel Function Restoration After Ileostomy Closure In Patients With Rectal Cancer
Official title: The Effect Of Probiotics From Kimchi (CJLP243) On Bowel Function Restoration After Ileostomy Closure In Patients With Rectal Cancer: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Cancer
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: HK inno.N Corporation
First posted: 2016-04-26
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will investigate whether Probiotics(CJLP243) given just before and after ileostomy repair operation in patient with rectal cancer improve a bowel function.


Eligibility criteria: Inclusion Criteria:

* Age: 20-75
* with rectal cancer
* s/p low anterior resection (double stapled anastomosis)

Exclusion Criteria:

* Metastatic cancer
* Pregnancy
* Valvular heart disease
* s/p intersphincteric resection (index surgery)
* h/o anastomotic leakage (index surgery)
* medically unfit (cardiopulmonary dysfunction, sepsis etc)

Primary outcomes:
measure: Memorial Sloan Kettering Cancer Center bowel function index
timeFrame: Postoperative weeks 3
measure: Low Anterior Resection Syndrome score
timeFrame: Postoperative weeks 3
Secondary outcomes:
measure: Memorial Sloan Kettering Cancer Center bowel function index
timeFrame: Postoperative week 1
measure: Low Anterior Resection Syndrome score
timeFrame: Postoperative week 1
measure: Change of bowel functions index
timeFrame: Between postoperative week 1 to 3
measure: EORTC C30
timeFrame: Postoperative week 1 and 3
measure: EORTC CR (Colorectal) 29
timeFrame: Postoperative week 1 and 3
measure: Postoperative complication
timeFrame: till Postoperative weeks 3
Other outcomes:
Locations:
Study officials:
References: