louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01166217: A Single Dose Study Of PF-04620110 In Healthy Subjects
Official title: A Phase 1, Cross-over, Single-dose, Open-label Study to Estimate the Relative Bioavailability of Three Different Formulations of Pf-04620110 Under Fed/Fasted Conditions in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Single Dose Study in Healthy Subjects
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2010-07-20
Enrollment: 12
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The primary purpose of this trial is to evaluate the relative bioavailability of three different oral dose formulations of PF-04620110.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 21 and 55 years
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at screening.

Primary outcomes:
measure: Pharmacokinetic Endpoints: Cmax, Tmax, AUClast, AUCinf, C24hr, peak trough ratio (PTR), and half life
timeFrame: following each treatment
Secondary outcomes:
measure: Safety Endpoints: Safety and tolerability of PF 04620110 will be assessed by physical examinations, adverse event monitoring, 12 lead electrocardiograms (ECGs), vital signs, and clinical safety laboratory measurements.
timeFrame: before, during and following treatment
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06433817: Spectral CT in Radiotherapy for Cervical Cancer
Official title: The Clinical Research of Spectral CT in Radiotherapy for Cervical Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cervical Cancer
Radiotherapy
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2024-05-30
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients with newly stablished diagnosis of cervical cancer complying with selection criteria for cervical cancer.

Brief summary: The purpose of this study was to explore the potential application of spectral CT for radiotherapy in cervical cancer.


Eligibility criteria: Inclusion Criteria:

1. All patients were confirmed cervical cancer by pathology
2. patients were treated with concurrent chemoradiotherapy
3. Spectral CT scans acquisition performed during the arterial phase and venous phase
4. All the patients underwent a 18F-FDG PET/CT before treatment

Exclusion Criteria:

1. CT without spectral scans
2. History of allergy to intravenous contrast
3. Pregnant or potentially pregnant female subjects

Primary outcomes:
measure: Comparison of spectral CT derived data with response evaluation in cervical cancer
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
measure: Identifying metastatic lymph nodes in cervical cancer with spectral CT
timeFrame: through study completion, an average of 2 year
measure: Application of energy spectrum CT in brachytherapy of cervical cancer
timeFrame: through study completion, an average of 2 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT01809717: Multiple Myeloma and Exercise
Official title: Modulating The Toxicity And Efficacy Of High Dose Chemotherapy For Multiple Myeloma Through An Intervention To Increase Lean Body Mass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Newly Diagnosed Multiple Myeloma
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2013-03-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study will establich the feasibility of weight lifting exercise among patients with multiple myeloma, determine if weight lifting exercise increases lean body mass among patients with multiple myeloma and obtain further preliminary data on toxicity and pharmacokinetics of high-dose melphalan.

Detailed description: This is a prospective, single-institution, pilot study of a 3 month weight lifting program designed to increase musle hypertrophy prior to starting stem cell collection and receiving high-dose melphalan, in patients with multiple myeloma. We will use this exercise intervention while patients are receiving initial induction chemotherapy in the 3-6 month period before they receiv high-dose melphalan. The primary study endpoint is to determine the feasibility of recruiting and retaining multiple myeloma patients to an exercise intervention trial. The secondary study endpoint is to determine whether the weight lifting program increases lean body mass as intended.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed multiple myeloma
* 1 year since start of treatment for myeloma
* Patient and treating physician in agreement to proceed with autologous transplant, with a planned time betwwen study enrollment and transplant of 10 weeks
* Age 18 years.
* Able to walk for 6 minutes unaided.
* Body mass index 50 kg/m2
* Serum creatinine 2.5 mg/dL
* Ability to understand the informed consent document and willingness to consent. Written informed consent must be obtained from all patients before study entry.

Exclusion Criteria:

* Recent (in the past 6 months) participation in progressive weight lifting exercises or who already exercise regulary (3 times a week of moderate intensity aerobic exercise).
* Plan to move out of the area during the study intervention.
* A psychological, social, or logistical barrier that the principal investigators feel would preclude completion of the study protocol.
* Plan for use of any anti-myeloma treatment other than melphalan (the use of total body irradiation will NOT

Primary outcomes:
measure: Number of Adverse Events
timeFrame: 3-6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the Unviersity of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson CC
name: Dan Vogl
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01969617: Effects of Nalmefene After Single Dose on the Blood Oxygen Level Dependent (BOLD) fMRI Signal in the Ventral Striatum to Reward Responding in the Monetary Incentive Delay Task (MIDT), in Non-treatment Seeking Subjects With Alcohol Dependence Following Alcohol Challenge
Official title: Interventional, Randomized, Double-blind, Cross-over, Placebo-controlled Study to Investigate the Effects of Nalmefene After Single Dose on the Blood Oxygen Level Dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signal in the Ventral Striatum to Reward Responding in the Monetary Incentive Delay Task (MIDT), in Non-treatment Seeking Subjects With Alcohol Dependence Following Alcohol Challenge
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alcohol Dependence
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2013-10-25
Enrollment: 22
Sex: MALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To contribute to the understanding of the underlying neurobiological mechanism behind the interaction of alcohol and nalmefene


Eligibility criteria: Inclusion Criteria:

* The subject has alcohol dependence, diagnosed according to DSM-IV-TR™.

Exclusion Criteria:

* The subject is seeking treatment for alcohol dependence.
* The subject has had \<6 heavy drinking days (HDDs) in the 4 weeks prior to the Screening Visit.
* The subject has had an average alcohol consumption below high risk levels (that is, 60 grams of alcohol/day for men) \<4 weeks prior to the Screening Visit.
* The subject has \>5 consecutive abstinence days in the 4 weeks prior to the Screening Visit.
* The subject has a Revised Clinical Institute Withdrawal Assessment of Alcohol Scale, (CIWA-Ar), score ≥10.
* The subject is, in the opinion of the investigator, at significant risk of suicide or meets the exclusion criteria based on C-SSRS.

Other inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Blood oxygen level dependent (BOLD) fMRI signal in the ventral striatum to reward responding using the monetary incentive delay task (MIDT) task
timeFrame: Day 1
Secondary outcomes:
measure: Safety
timeFrame: Up to Day 8 and a 10-day safety follow up
measure: Risk of suicidality
timeFrame: Up to Day 8
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: GB801
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
citation: Quelch DR, Mick I, McGonigle J, Ramos AC, Flechais RSA, Bolstridge M, Rabiner E, Wall MB, Newbould RD, Steiniger-Brach B, van den Berg F, Boyce M, Ostergaard Nilausen D, Breuning Sluth L, Meulien D, von der Goltz C, Nutt D, Lingford-Hughes A. Nalmefene Reduces Reward Anticipation in Alcohol Dependence: An Experimental Functional Magnetic Resonance Imaging Study. Biol Psychiatry. 2017 Jun 1;81(11):941-948. doi: 10.1016/j.biopsych.2016.12.029. Epub 2017 Jan 10.
Clinical trial NCT03176017: Ejaculatory Sparing Transurethral Incision Of The Prostate (ES-TUIP) Versus Conventional TUIP
Official title: Ejaculatory Sparing Transurethral Incision Of The Prostate (ES-TUIP) Versus Conventional TUIP
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Hyperplasia
Transurethral Incision Of The Prostate
Ejaculatory Dysfunction
Keywords: Transurethral Incision Of The Prostate
Prostate
Ejaculatory Sparing
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2017-06-05
Enrollment: 40
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, Investigators planned to compare ejaculatory sparing and non-ejaculatory sparing (conventional) TUIP using both subjective and objective assessment tools for the degree of deobstruction.

Furthermore, the impact of both techniques on ejaculation and its secondary effect on orgasm perception and different domains of sexual function will be thoroughly assessed.


Eligibility criteria: Inclusion Criteria:

* American society of anesthesiologists (ASA) score ≤3.
* TRUS estimated prostate weight ≤ 35 grams.
* Sexually interested and having continuous relationship with the same partner (interested).
* Bladder outlet obstruction index (BOOI ) ≥ 20 as per pressure flow study

Exclusion Criteria:

* Preoperative sexual or ejaculatory disturbances or pelvic pain syndrome
* Neurological disorders that can affect potency and ejaculation e.g. long standing uncontrolled diabetes mellitus (DM) type 2 (\> 10 years), DM type 1, cerebral stroke, Parkinsonism
* Urodynamic changes consistent with urethropathy or detrusor hypocontractility
* Previous pelvic surgeries or radiotherapy

Primary outcomes:
measure: impact on ejaculatory function and subsequently the impact of reported ejaculatory changes on orgasm perception
timeFrame: 1 year
Secondary outcomes:
measure: Erectile function domains (erectile function, orgasm, desire, intercourse satisfaction and overall satisfaction)
timeFrame: 1 year
measure: Patient reported functional urinary outcomes
timeFrame: 1 year
measure: maximum flow rate (Q.max)
timeFrame: 1 year
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Urology and Nephrology Center
state: Aldakahlia
Study officials:
affiliation: Urology and Nephrology center
name: Ahmed M Shoma, MD
role: STUDY_CHAIR
affiliation: Urology and Nephrology center
name: Nasr Eltabey, MD
role: STUDY_DIRECTOR
affiliation: Urology and Nephrology center
name: Ahmed N Elshal, MD
role: STUDY_DIRECTOR
affiliation: Urology and Nephrology center
name: Mahmoud Laimon, Msc
role: PRINCIPAL_INVESTIGATOR
affiliation: Mansoura University
name: Ahmed Elkashef
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03469817: Maveric Magnetic Resonance Imaging Used to Study Detailed Bone Apposition and Fixation of the Stryker Trident II Tritanium System
Official title: Maveric Magnetic Resonance Imaging Used to Study Detailed Bone Apposition and Fixation of the Stryker Trident II Tritanium System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Hip Pain
Keywords: Bone apposition
Stryker
MRI
Trident II
Total Hip Replacement
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
Collaborators: name: Stryker Nordic
First posted: 2018-03-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1 control group who have had been implanted with a Trident cup and have already had MRIs taken at their one year post-operative visit. This group's MRI's will be compared with MRI's from Tridend II patients who have had MRI's at 1 year post-operative visit.
Primary purpose: OTHER

Brief summary: The study aims to describe bone apposition and fixation of the Trident and Trident II Tritatnium acetabular system in patients 1 year status post total hip replacement. We will be studying this by comparing magnetic resonance imaging (MRI)s taken 1 year s/p total hip replacement with a Trident II cup with MRI's taken of patients with the Trident Cup who had MRIs done at 1 year post-op.


Eligibility criteria: Inclusion Criteria:

1. Patients who had a primary total hip replacement with a Stryker Trident II acetabular cup that have one year or more follow up.
2. Patients that are willing able able to have an MRI at their one year follow up visit.
3. Patients entered into the CORRe database (our HSS institutional joint replacement registry).

Exclusion Criteria:

1. Patients who have not been consented as part of the CORRe database.
2. Patients who are unable or refuse to have an MRI at their 1 year follow up.

Primary outcomes:
measure: Comparison of bone apposition and fixation in patients with the Trident II Tritanium hip system with bone apposition and fixation in patients with Trident cups.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
References:
Clinical trial NCT01301417: Data Collection of Patients Treated With the ColonRing™ for the Creation of Circular Compression Anastomosis
Official title: a RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing ™
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diverticulum, Colon
Colorectal Neoplasms
Crohn Disease
Colitis, Ulcerative
Colostomy
Ileostomy - Stoma
Rectal Prolapse
Intestinal Polyposis
Lymphoma
Endometriosis
Intestinal Volvulus
Keywords: Compression Anastomosis
Lead sponsor: novoGI
Sponsor class: INDUSTRY
First posted: 2011-02-23
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult Patients who underwent a laparoscopic or open colorectal resection with the creation of an anastomosis using the ColonRing™ in routine clinical practice.

Brief summary: The proposed study is a post marketing, observational, retrospective data collection intended to gather and record data on patients treated with the ColonRing™ device in routine clinical practice at a single center. The data will assist in further evaluating the performance of the ColonRing™ device in regards to the creation of a colorectal anastomosis.

Hypothesis:The performance of the ColonRing™, determined by the rate of complications, will be within the acceptable range reported in the literature for alternative treatment modalities.


Eligibility criteria: Inclusion Criteria:

* Patient was \> 18 years old at time of procedure
* Patient underwent an open or laparoscopic colorectal procedure with the creation of an anastomosis using the ColonRing™
* Patient treated in routine clinical practice following marketing clearance of the device within the cleared intended use
* Patient underwent his/her first follow-up visit within two months post-surgery

Exclusion Criteria:

* No exclusion criteria have been defined for this data collection.

Primary outcomes:
measure: Rate of anastomotic leakage
timeFrame: 2-mo post-op
Secondary outcomes:
measure: Rate of other device related complications and measures during hospitalization and post procedure:
timeFrame: 2-mo post-op
Other outcomes:
Locations:
city: Riverdale
country: United States
facility: Southern Regional Medical Center
state: Georgia
Study officials:
affiliation: novoGI
name: Eran Choman, Msc
role: STUDY_DIRECTOR
References:
Clinical trial NCT06493617: Does Cervical Mobilization Have an Effect on Hand Function in Patients With Double Crush Syndrome?
Official title: Does Cervical Mobilization Have an Effect on Hand Function in Patients With Double Crush Syndrome?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Double Crush Syndrome
Keywords: cervical mobilization
hand function
double crush syndrome
Lead sponsor: AlRyada University for Science & Technology
Sponsor class: OTHER
First posted: 2024-07-10
Enrollment: 30
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: All Double Crush Syndrome patients were assessed via VAS, BCTQ \& Nerve conduction study before and after the treatment program.

Detailed description: The patients were classified randomly into two groups, the control group received a standard physical therapy program of nerve glide, hand strengthening exercise and mobilization and the study group they received a cervical mobilization in addition to the standard physical therapy program for 12 sessions.

Eligibility criteria: Inclusion Criteria:

* Thirty female patients diagnosed as Double Crush Syndrome based on the clinical diagnostic criteria of the American Academy of Neurology, (American Academy of Neurology 2019).
* Patient ages ranged from 25 to 35 years old. Patient who reported pain, hyperesthesia, and/or paresthesia at the course of median nerve distribution and upper limb.
* A Nerve Conduction Study (NCS) evidence of peripheral entrapment of median nerve at level of carpal bone "Carpal tunnel Syndrome" with a fractionated sensory nerve conduction velocity for the median nerve across the wrist of 40 m/s or less and with sensory peak latency \> 3.6 ms and recordable and with motor distal latency \>4.4 ms and less than 6.5ms.

Exclusion Criteria:

* Patients had Systemic disease causes double Crush Syndrome as rheumatoid arthritis (RA), thyroid disease, Diabetes mellitus (DM), Pregnant women, Patients with concomitant neurological disease as peripheral neuropathy, Patients with history of wrist surgery, fracture, or carpal tunnel injection in the last two weeks before the study, Patients who have wasting of the thenar muscles, Patients with previous surgery for CTS.
* Patients with complete conduction block on EDX or previous regular exposure to hand-held vibrating tools, Patients with Nerve Conduction Study with motor distal latency \> 6.5 ms.

Primary outcomes:
measure: Visual analogue scale
timeFrame: 4 weeks
measure: Boston carpal tunnel syndrome questionnaire
timeFrame: 4 weeks
measure: Nerve conduction study
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sadat
country: Egypt
facility: Al Ryada University for Science and Technology
state: Menoufia
Study officials:
References:
Clinical trial NCT00422617: Evaluate the Efficacy and Safety of One Course of Amevive in Taiwan Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Plaque Psoriasis
Keywords: psoriasis
alefacept
Lead sponsor: Uni-Pharma
Sponsor class: INDUSTRY
Collaborators: name: Biogen
First posted: 2007-01-17
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: ECT

Brief summary: An open-label, multicentre study to evaluate the efficacy and safety of one course of weekly intramuscular administration of Amevive in Taiwan patients with chronic plaque psoriasis

Detailed description: The purpose of the present study is to establish the efficacy and safety of one course of once weekly 15 mg intramuscular (IM) administration of AMEVIVE in an alternate study population and to address the issue of peak time to response by measuring the proportion of patients achieving a ≥ 75% reduction in PASI at any time after completion of treatment.

Eligibility criteria: Inclusion Criteria:

* Must give written informed consent
* Must be \>= 16 years of age
* Must have been diagnosed with chronic plaque psoriasis at least one year and require systemic or phototherapy
* Must have CD4+ lymphocyte count at or above the lower limit of normal
* Must have a BSA \>= 10%

Exclusion Criteria:

* Current erythrodermic, generalized pustular, or guttate psoriasis
* Serious local infection or systemic infection within 3 months prior to the first dose of alefacept
* History of any clinical significant disease that would be contraindicated for this study as determined by the investigator
* Prior history of systemic malignancy, untreated localised skin canceer or a \>10 squamous cell carcinoma
* Current enrollment in any other investigational drug study within 30 days prior to study drug administration
* Treatment with systemic immunosuppressant agents within the 4 weeks prior to study drug administration.

Primary outcomes:
measure: To determine TRR75 of one course of once weekly 15 mg intramuscular (IM) administration of AMEVIVE
Secondary outcomes:
measure: To determine TRR50, Quality of Life (QOL), the safety and tolerability
Other outcomes:
Locations:
Study officials:
affiliation: CGMH
name: Po-Han Huang
role: PRINCIPAL_INVESTIGATOR
References: