louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00946491: To Demonstrate the Relative Bioequivalency of Generic Haloperidol Tablets Versus Haldol in Normal Volunteers
Official title: An Open-Label, Single-Dose, Crossover Study to Determine the Bioequivalency of Generic Haloperidol Tablets vs. Haldol in Normal Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psychosis
Keywords: Typical Antipsychotic
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-07-27
Enrollment: 30
Sex: MALE
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To demonstrate the relative bioequivalency of generic Haloperidol tablets versus Haldol in normal volunteers.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 17 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Quincy Research Center
name: Philip T. Leese, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04798391: Effectiveness of Intratympanic Dexamethasone With Ligmocaine for Alleviation of Tinnitus
Official title: Effectiveness of Dexamethasone With Lignocaine for Alleviation of Tinnitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Tinnitus
Lead sponsor: Combined Military Hospital, Pakistan
Sponsor class: OTHER
First posted: 2021-03-15
Enrollment: 264
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Objective: To determine the effectiveness of Intratympanic dexamethasone with lignocaine in control of idiopathic tinnitus.

Methodology: 264 consenting patients with idiopathic unilateral tinnitus presenting at ENT Department were assessed for tinnitus severity using Modified Tinnitus Handicap Inventory and the scores recorded and subsequently administered intratympanically 2.0 ml (milliliter's) of dexamethasone and lignocaine (1.5 ml dexamethasone + 0.5 ml 1% lignocaine). The dose was repeated twice at weekly intervals. All patients were re assessed on Modified Tinnitus Handicap Inventory two weeks after third Intratympanic administration.


Eligibility criteria: Inclusion Criteria:

* score 20 or above on modified tinnitus handicap inventory

Exclusion Criteria:

* head trauma, tympanic membrane perforation, depression, ear surgery

Primary outcomes:
measure: Tinnitus relief
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Quetta
country: Pakistan
facility: Combined Military Hospital
state: Balochistan
Study officials:
References:
Clinical trial NCT06480591: Evaluation of the Pathobiology of CALR-mutated MPN Cells
Official title: Evaluation of the Pathobiology of CALR-mutated MPN Cells
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myeloproliferative Neoplasm
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Atrium Health Levine Cancer Institute
name: Brookdale University Hospital Medical Center
First posted: 2024-06-28
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients seen in the clinic with MPN with the CALR mutation will be identified and approached for consent.

Brief summary: The purpose of this study is to understand why there is a greater risk of thrombosis in patients who have the JAK2 mutation as compared to those with CALR mutations.

Detailed description: This biospecimen study is designed to evaluate the expression levels of TLR 2 and TLR 4 on mononuclear cells in CALR mutation positive MPN participants and compare to JAK2 V617F mutation positive MPN patients and healthy controls. Patients who have MPN with the CALR mutation positive will be approached for interest in participating in this study. A research blood collection will occur at any time during the participant's cancer trajectory after enrollment, during a standard of care blood draw. The participant's demographics, MPN subtype, CALR mutation status, history of thrombosis/other medical history, and current, concomitant medications will be collected once. Clinical data will be collected, including results from the CBC with differential, complete metabolic panel (if available), and PT/PTT/INR (if available) drawn closest to the research blood collection. This study will initially open as a single center study at AHWFBCCC.

Eligibility criteria: Inclusion Criteria:

* Written (or electronic) informed consent and HIPAA authorization for release of personal health information by participant or his/her legally authorized representative (LAR).
* Age ≥ 18 years at the time of enrollment
* Diagnosis of myeloproliferative neoplasm (MPN) according to 2022 World Health Organization classification of MDS/MPNs
* CALR-positive genetic mutation

Exclusion Criteria:

- Diagnosis of MPN with JAK2 V617F mutation

Primary outcomes:
measure: Expression levels of TLR 2 and TLR 4
timeFrame: 24 months
Secondary outcomes:
measure: Plasma levels of inflammatory cytokines
timeFrame: 24 months
measure: Plasma levels of inflammatory cytokines following incorporation of TLR ligands
timeFrame: 24 months
measure: History of thrombosis
timeFrame: 24 months
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Atrium Health Levine Cancer
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Atrium Health Levine Cancer
name: Aleksander Chojecki, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01609491: Phenylephrine Versus Norepinephrine in Ophthalmic Surgery
Official title: Comparison of the Effects of Phenylephrine and Norepinephrine on Hemodynamics and Tissue Oxygenation in Patients Undergoing Ophthalmic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bloodpressure
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2012-06-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In ophthalmic surgery the specific anaesthesiological challenges necessitate the administration of a combination of relatively high doses of hypnotics and analgetics. In order to preserve adequate organ perfusion, there is often a need to administer pharmacological agents for haemodynamic support. Depending on the experience of the anaesthetist a continuous infusion of phenylephrine or norepinephrine is used. It is currently not known which of these agents has the most favorable haemodynamical profile.

Haemodynamic parameters (continuous blood pressure, cardiac index, stroke volume and systemic resistance), peripheral tissue oxygenation and cerebral tissue oxygenation will be monitored noninvasively using the Nexfin® , Inspectra®, and Foresight® and O2C® monitoring devices.


Eligibility criteria: Inclusion Criteria:

Patients requiring general anaesthesia for ophthalmic surgery.

* Age \> 18 years and older
* Diabetes or cardiovascular disease or age \>55 years

Exclusion Criteria:

* Patient refusal
* Patient \< 18 years

Primary outcomes:
measure: the haemodynamical effects of norepinephrine and phenylephrine during ophthalmic surgery
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: Anesthesiology
name: Alain Kalmar, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05679791: Comparative Study of Static and Dynamic Hand Grip Endurance in Pregnancy
Official title: Comparative Study of Static and Dynamic Hand Grip Endurance With Correlation of Deep Breathing Among Pregnant Women; A Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hand Grasp
Pregnancy Related
Lead sponsor: Central Park Medical College
Sponsor class: OTHER
Collaborators: name: Shalamar Teaching Hospital
First posted: 2023-01-11
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Females

Brief summary: Background: Physiology of the mother, changes constantly during pregnancy including reduced HGS that is require for carrying the child after delivery. Activities of daily living require manual gripping tasks that require dynamic and static contractions. Predictor of upper extremity function is Hand Grip Strength and handgrip endurance. Screening of hand grip strength during antenatal care is still uncommon.

Objectives: To compare static and dynamic hand grip endurance in pregnant females and to find its correlation with deep breathing.

Material and Methods: The study recruited 40 participants of primi-gravida of 1st and 2nd trimester, between ages 20 and 35 years from SHALAMAR GYNAE OPD. The participants assigned to the groups (Group 1: with DB, Group 2: without DB) based on their trimester and gravidity. Static and dynamic endurance assessed using hand held dynamometer.

Key words: Pregnancy, deep breathing, trimester, endurance, peak grip endurance


Eligibility criteria: Inclusion Criteria:

* primigravida

Exclusion Criteria:

* multigravida
* Cardiac patients

Primary outcomes:
measure: hand grip in pregnancy
timeFrame: feb 2022 to aug 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Central Park Medical College
state: Punjab
Study officials:
References:
Clinical trial NCT02640391: Predictive Factors of Endoscopic Mucosal Healing in Quiescent Ulcerative Colitis
Official title: Predictive Factors of Endoscopic Mucosal Healing in Quiescent Ulcerative Colitis: Prospective Observational Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis
Keywords: Ulcerative colitis
fecal calprotectin
mucosal healing
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2015-12-29
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with inactive UC (Mayo score \<3) who are scheduled to undergo colonoscopy for surveillance or mucosal healing check-up

Brief summary: The purpose of this study is to determine whether fecal calprotectin, fecal immunochemical test, and Rome III criteria for irritable bowel syndrome (IBS) can predict mucosal healing in patients with quiescent ulcerative colitis (UC).


Eligibility criteria: Inclusion Criteria:

* Patients with ulcerative colitis who have no change of medication for at least 6 months
* Patients with ulcerative colitis who are in remission (Mayo score \<3)
* Patients with ulcerative colitis who will undergo colonoscopy for surveillance or mucosal healing check-up

Exclusion Criteria:

* Patients who refuse to participate
* Patients who have a history of colectomy
* Patients who have instinal stricture or perforation

Primary outcomes:
measure: Mucosal healing
timeFrame: 1 week
measure: Fecal calprotectin
timeFrame: 1 week
measure: Fecal immunochemical test
timeFrame: 1 week
Secondary outcomes:
measure: Rome III criteria for IBS
timeFrame: 1 week
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
Study officials:
affiliation: Keimyung University School of Medicine
name: Eun Soo Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06210191: Intramedullary Headless Screw Fixation for Metacarpal and Phalangeal Fractures
Official title: Intramedullary Headless Screw Fixation for Metacarpal and Phalangeal Fractures
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Metacarpal Fracture
Phalanx Fracture
Keywords: intramedullary headless screw fixation
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 35
Sex: ALL
Minimum age (years): 16
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Intramedullary headless screw fixation for metacarpal and phalangeal fractures

Detailed description: The most frequent fractures in the upper extremities are phalangeal and metacarpal fractures accounts about 40%, which follow distal radius fractures in order of frequency.

There are many methods of fixation of these fractures as plates and K-wires. Plate fixation is able to provide open reduction and stability for early range of motion with mixed clinical results. Reported complications include stiffness, fixed flexion contracture of the adjacent joints, soft tissue dissection, and extensor lag.

There are minimally invasive techniques, including the use of K-wires, lag screws, cerclage wiring, and external fixation that limit soft tissue dissection. These options have drawbacks of malunion, nonunion, infection, need for hardware removal, and stiffness.

Intramedullary headless screw fixation is an emerging alternative to K-wire or plate fixation of displaced and unstable fractures of the phalanges and metacarpals. The Intramedullary headless screw fixation is a new option that offers rigid stability, early active range of motion, and easy insertion. Due to the minimally invasive nature of this technique, patients will experience better results in terms of range of motion, return to work faster, and minimize complications.

Beck et al. reported 100% of patients achieved full radiological union with minor complication rate and full range of motion and early return to work with average 96% of grip strength.

Eligibility criteria: Inclusion Criteria:

1. Skeletally mature patients with closed fractures of phalanges and metacarpals.
2. Patients with open type I fractures of phalanges and metacarpals.

Exclusion Criteria:

1. Skeletally immature patients with open physis.
2. Patients with open type II or III fractures of phalanges or metacarpals.
3. Patients with fractures of phalanges or metacarpals with neurovascular injury. 4 Patients with associated tendon injuries.

Primary outcomes:
measure: Achieve full range of motion of hand joints
timeFrame: 6 weeks for active range of motion
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of medicine
Study officials:
affiliation: Assiut University
name: Amr Elsayed, professor
role: STUDY_CHAIR
affiliation: Assiut University
name: Waleed Riad, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05401591: Microalgae as an Alternative Protein Source in Human Nutrition.
Official title: Microalgae as an Alternative Protein Source in Human Nutrition.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition, Healthy
Lead sponsor: University of Exeter
Sponsor class: OTHER
Collaborators: name: The University of Queensland
First posted: 2022-06-02
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Protein is an essential part of the human diet. But with a growing global population and climate emergency, current sources of dietary protein are unable to continue to sustainably meet the global demand. To ensure future food security, new sustainable protein sources are required. Microalgae - a group of plant-like single cells - are thought to be a good option due to their sustainable farming methods and naturally high protein content. Long term health benefits of eating microalgae have been seen in humans. However, the time directly following microalgae ingestion has not been well studied but is an important period when considering a protein source. This research will compare the period after ingestion of three preparations and/or types of microalgae to a traditional source of protein.


Eligibility criteria: Inclusion Criteria:

* BMI 18.5 -30 kg/m2
* age 18 - 40 years
* healthy
* non-smoker

Exclusion Criteria:

* BMI \<18.5 or \>30 kg/m2
* smoker
* metabolic disease
* relevant food intolerance
* using medications known to affect metabolism

Primary outcomes:
measure: Plasma amino acids
timeFrame: 5 hours postprandial
Secondary outcomes:
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: Exeter University
Study officials:
References:
Clinical trial NCT06670391: A Retrospective Study in Patients With Liver Injury After the Use of Novel Antineoplastic Agents
Official title: A Retrospective, Real-world, Electronic Medical Record-based Study on Patients With Liver Injury After the Administration of Novel Antineoplastic Agents
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Liver Injury
Liver Injury, Drug-Induced
Lead sponsor: Drug Induced Liver Disease Study Group
Sponsor class: OTHER
First posted: 2024-11-01
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All hospitalized patients from participating medical centers.

Brief summary: This is an open-enrollment, retrospective, observational study without interventions. Its primary objective is to understand 1) incidence of liver injury among all the hospitalized patient from participating centers after the administration of immune checkpoint inhibitors or molecularly targeted agents; 2) epidemiologic and clinical characteristics of liver injury, including suspected medications, clinical types, histological characteristics, severity, treatment and outcomes.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Abnormality of liver biochemistry after the administration of any molecularly targeted agent or immune checkpoint inhibitor

Exclusion Criteria:

* Missing major baseline or clinical data
* Prior liver loco-regional therapy or surgery

Primary outcomes:
measure: Change in ALT (alanine aminotransferase)
timeFrame: on day 10
Secondary outcomes:
measure: Proportion of patients with normalized liver biochemistry
timeFrame: on day 3, 7, 10, 14, 21, and 30
measure: Change in liver biochemistry
timeFrame: on day 3, 7, 10, 14, 21, and 30
measure: Time to normalization of liver biochemistry
timeFrame: up to 6 month
measure: Proportion of patients with ≥ 50% reduction in liver biochemistry
timeFrame: on day 3, 7, 10, 14, 21, and 30
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
References:
Clinical trial NCT01955291: Reinforced Feedback in Virtual Environment
Official title: The Role of Virtual Therapy by Means of Reinforced Feedback in Virtual Environment on Upper Limb Function in Post-stroke Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Virtual Reality, Motor Learning, Rehabilitation, Upper Limb
Lead sponsor: IRCCS San Camillo, Venezia, Italy
Sponsor class: OTHER
First posted: 2013-10-07
Enrollment: 136
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: The aims of the study is to explore whether the rehabilitation of the upper extremity performed in interaction with a virtual environment could improve motor function in post-ischemic and post-haemorrhagic stroke subjects with hemiparesis, in comparison to the traditional neuromotor rehabilitation treatment.


Eligibility criteria: Inclusion Criteria:

* patients affected by a stroke occurring in the period no longer than 1 year before the enrolment
* both first ischemic and hemorrhagic stroke
* subjects who did not had RFVE treatment previously
* scoring higher than 24 points in the Mini-Mental State Examination test

Exclusion Criteria:

* upper extremity complete hemiplegia
* upper limbs sensory disorders
* clinical evidence of cognitive impairment
* neglect
* apraxia
* comprehension difficulties
* post-traumatic injury of the upper limb

Primary outcomes:
measure: Fugl_Meyer Upper Extremity scale (F-M UE)
timeFrame: 20 min
Secondary outcomes:
measure: Functional Independence Measure scale (FIM)
timeFrame: 20 min
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: 5 min
measure: Kinematic assessment
timeFrame: 30 min
Other outcomes:
measure: Edmonton Symptom Assessment Scale (ESAS)
timeFrame: 5 min
measure: Modified Ashworth scale
timeFrame: 10 min
measure: Mini Mental State Examination scale (MMSE)
timeFrame: 20 min
Locations:
city: Venezia
country: Italy
facility: Fondazione Ospedale San Camillo IRCCS
state: Veneto
Study officials:
affiliation: Fondazione Ospedale San Camillo IRCCS
name: Paolo Tonin, MD
role: STUDY_DIRECTOR
References:
citation: Laver K, George S, Thomas S, Deutsch JE, Crotty M. Cochrane review: virtual reality for stroke rehabilitation. Eur J Phys Rehabil Med. 2012 Sep;48(3):523-30. Epub 2012 Jun 20.
citation: Kiper P, Agostini M, Luque-Moreno C, Tonin P, Turolla A. Reinforced feedback in virtual environment for rehabilitation of upper extremity dysfunction after stroke: preliminary data from a randomized controlled trial. Biomed Res Int. 2014;2014:752128. doi: 10.1155/2014/752128. Epub 2014 Mar 13.
citation: Kiper P, Szczudlik A, Agostini M, Opara J, Nowobilski R, Ventura L, Tonin P, Turolla A. Virtual Reality for Upper Limb Rehabilitation in Subacute and Chronic Stroke: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 May;99(5):834-842.e4. doi: 10.1016/j.apmr.2018.01.023. Epub 2018 Feb 14.