louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02404766: Effects of C0-C1 Mobilization in the Neutral Position in Subjects With Upper Cervical Rotational Hypomobility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Upper Cervical Spine Rotational Hypomobility
Keywords: manual therapy
cervical
range of movement
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
First posted: 2015-03-31
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: C1-C2 is the most mobile segment of the spine and its dysfunction is frequently associated to cervical pain and headache. However, serious neurovascular adverse effects have been documented through direct treatment of C1-C2 segment. Although indirect treatment via adjacent segments and avoidance of end range of rotation and extension have been recommended for a safer and effective cervical treatment, there is no scientific evidence of the effectiveness of the indirect treatment approach in the cervical neutral position for C1-C2 hypomobility.

Due to that, the investigators designed a randomized controlled trial to compare the short-term effects in the Flexion Rotation Test (FRT) of a translatoric mobilization of C0-C1, a translatoric mobilization of C7-T1 and a control group in subjects with C1-C2 hypomobility.The primary hypothesis is that C0-C1 dorsal glide mobilization applied in the neutral cervical position can recover the C1-C2 rotational range of movement in subjects with upper cervical hypomobility.


Eligibility criteria: Inclusion Criteria:

* FRT with less than 32º or asymmetry of 10º between right and left, whenever one of the sides does not exceed physiological C1-C2 ROM (45º)
* Indication of grade III mobilization in C0-C1 and C7-T1 segments
* Aged 18-66
* Signed informed consent

Exclusion Criteria:

* Contraindication to manual therapy and red flags according to Rushton et al. (2012)
* Pain presence at the beginning or during the study
* Cervical treatment during the last three months
* Inability to tolerate FRT
* Involvement in litigation or compensation

Primary outcomes:
measure: Change in baseline in Range of movement in Upper Cervical Spine
timeFrame: 1 hour after intervention
Secondary outcomes:
measure: Cervical range of movement in cardinal planes
timeFrame: 1 hour after intervention
measure: Upper cervical flexion and extension range of movement
timeFrame: 1 hour after intervention
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: César Hidalgo
state: Aragón
Study officials:
References:
Clinical trial NCT04432766: A Phase 1/2 Study to Assess Safety and Efficacy of BAT2020 in Hospitalized COVID-19 Patients
Official title: A Phase 1/2, Multi-Center, Randomized Study to Assess Safety, Pharmacokinetics, Immunogenicity, and Efficacy of BAT2020 in Hospitalized Patients Infected With SARS-CoV-2 (COVID-19)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: COVID-19
Lead sponsor: Bio-Thera Solutions
Sponsor class: INDUSTRY
First posted: 2020-06-16
Enrollment: 0
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: This is a randomized study to assess safety, pharmacokinetics, immunogenicity, and efficacy of BAT2020 in hospitalized patients infected with COVID-19. This study is composed of 2 Parts: a single ascending dose (Part 1) and single dose(s) tested in parallel with a double-blind, placebo-controlled design (Part 2). Patients also will receive best available standard of care (SOC) treatment. A data and safety monitoring board (DSMB) will be set up for the study.


Eligibility criteria: 1. Male or nonpregnant female adult ≥18 years of age at time of enrollment.
2. Patient (or legally authorized representative) provides informed consent prior to initiation of any study procedures.
3. Agrees to the collection of nasopharyngeal swabs for virology assessment.
4. Women of childbearing potential must agree to either abstinence or use at least 1 primary form of contraception at the time of screening and for 4 months after study drug dosing.
5. Enrollment within 72 hours of hospital admission.

Primary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Idaho Falls
country: United States
facility: Snake River Research
state: Idaho
Study officials:
References:
Clinical trial NCT03308266: Electromyographic Analysis of the Masticatory Muscles in Cleft Lip and Palate Children With Temporomandibular Disorders
Official title: Electromyographic Analysis of the Masticatory Muscles in Cleft Lip and Palate Children With Pain-related Temporomandibular Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cleft Lip and Palate
Temporomandibular Disorder
Lead sponsor: Pomeranian Medical University Szczecin
Sponsor class: OTHER
First posted: 2017-10-12
Enrollment: 87
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The subjects were selected from patients who had been referred to three Cleft Care Centres in Szczecin, Poznań and Wrocław, Poland.

Brief summary: The aim of this study was to assess the electrical activity of the temporal and masseter muscles in cleft lip and palate (CLP) children with pain-related temporomandibular disorders (TMD) and in CLP individuals with no TMD by means of surface electromyography (sEMG). Another objective was to determine the diagnostic value of electromyography in identifying CLP patients with temporomandibular disorders. The sample comprised 87 children with CLP and mixed dentition. The children were assessed for the presence of TMD using of the Research Diagnostic Criteria for TMD (RDC/TMD) by a single examiner. A DAB-Bluetooth Instrument (Zebris Medical GmbH, Germany) was used to take electromyographical (EMG) recordings of the temporal and masseter muscles both in the mandibular rest position and during maximum voluntary contraction (MVC).


Eligibility criteria: Inclusion Criteria:

* presence of a cleft without a syndrome, a sequence, or karyotype abnormalities
* presence of mixed dentition

Exclusion Criteria:

* the presence of systemic or rheumatologic diseases
* a history of cervical spine or temporomandibular joint (TMJ) surgery, trauma or malformations

Primary outcomes:
measure: Electromyographic analysis of the masticatory muscles in cleft lip and palate children with pain-related temporomandibular disorders
timeFrame: For a single subject the whole EMG examination was taken 40 minutes.
Secondary outcomes:
measure: The diagnostic value of electromyography in identifying cleft lip and palate patients with temporomandibular disorders
timeFrame: For a single subject the whole EMG examination was taken 40 minutes.
Other outcomes:
Locations:
city: Szczecin
country: Poland
facility: Pomeranian Medical University, Department of Orthodontics
Study officials:
References:
citation: Szyszka-Sommerfeld L, Machoy M, Lipski M, Wozniak K. The Diagnostic Value of Electromyography in Identifying Patients With Pain-Related Temporomandibular Disorders. Front Neurol. 2019 Mar 5;10:180. doi: 10.3389/fneur.2019.00180. eCollection 2019.
Clinical trial NCT03765866: Rotational Thromboelastometry Activated Transfusion In Trauma Trial
Official title: Viscoelastic Guided Goal Directed Resuscitation of Severely Injured Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trauma
Keywords: rotational thromboelastometry
viscoelastic test
coagulopathy
trauma
hemorrhage
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2018-12-05
Enrollment: 31
Sex: ALL
Minimum age (years): 14
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled trial to compare viscoelastic (VE) guided resuscitation to fixed-ratio resuscitation in trauma patients with hemorrhagic shock on the utilization of blood products, effects on coagulation and inflammatory mediators, and how these strategies affect post resuscitation adverse events.

Detailed description: This is an open labeled study as the VE guided resuscitation will be based on the visible VE results. Aim 1 will compare the number of blood products utilized in each resuscitation strategy. Aim 2 will analyze the coagulation and inflammatory mediators in each resuscitation strategy to determine if there is a difference in the mechanism of coagulopathy. Aim 3 will determine if the different resuscitation strategies have an effect on post resuscitation adverse events.

Eligibility criteria: Inclusion Criteria:

1. Trauma patient
2. MTP Activation
3. Only patients ≥ 14 years old
4. Alive at 31 mins after arrival in ED

Exclusion Criteria:

1. Transfer from OSH
2. Received CPR for more than 5 mins
3. Burned
4. Pregnant or Prisoner
5. Known DNR
6. Jehovah's witness

Primary outcomes:
measure: Change in number of blood products utilized at 24 hours
timeFrame: 24 hours from time of randomization
Secondary outcomes:
measure: Change in coagulation profile
timeFrame: 0 hours and 30 days
measure: Change in inflammatory mediators
timeFrame: 0 hours and 30 days
measure: Changes in Resuscitation strategy-related adverse events
timeFrame: 30 days after admission
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Parkland Memorial Hospital
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Michael W. Cripps, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schlimp CJ, Voelckel W, Inaba K, Maegele M, Schochl H. Impact of fibrinogen concentrate alone or with prothrombin complex concentrate (+/- fresh frozen plasma) on plasma fibrinogen level and fibrin-based clot strength (FIBTEM) in major trauma: a retrospective study. Scand J Trauma Resusc Emerg Med. 2013 Oct 8;21:74. doi: 10.1186/1757-7241-21-74.
Clinical trial NCT00370266: Intravitreal Triamcinolone for Acute Branch Retinal Vein Occlusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Branch Retinal Vein Occlusion
Keywords: Macular edema
Branch retinal vein occlusion
Intravitreal triamcinolone
Macular thickness
Retinal neovascularization
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2006-08-31
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether intraocular injection of triamcinolone is effective in the treatment of macular edema in acute branch retinal vein occlusion.

Detailed description: Intravitreal triamcinolone has recently been shown to have beneficial effect on chronic macular edema due to vein occlusion and preventive effect on neovascularization. Hypothetically, prevention of macular derangement by reducing the amount of edema from early phase after occlusion until restoration of collaterals seems to be helpful in these eyes. To our knowledge, no prospective randomized clinical trial, considering both macular changes and preventive effect on neovascularization has been published for intravitreal triamcinolone in acute branch retinal vein occlusion.

Eligibility criteria: Inclusion Criteria:

* Eyes suffering from branch retinal vein occlusion with less than 2 months duration.

Exclusion Criteria:

* Monocularity,
* Previous intraocular surgery or laser therapy
* Glaucoma or ocular hypertension
* Significant media opacity
* Existence of traction on the macula
* Visual acuity ≥20/40
* Signs of chronicity (such as cilioretinal and/or retinal shunt vessels)

Primary outcomes:
measure: Central macular thickness
Secondary outcomes:
measure: Visual acuity
measure: Retinal neovascularization
measure: Intraocular pressure
measure: Cataract progression
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Alireza Ramezani, MD
Study officials:
affiliation: Ophthalmic Research Center of Shaheed Beheshti Medical University
name: Alireza Ramezani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01491126: Single Center Open Prospective Study for the Comparison of Procedural Sequence in Same Day Consecutive Bidirectional Endoscopy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bidirectional Endoscopy
Keywords: Gastroscopy
Colonoscopy
Anesthesia
Recovery
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2011-12-13
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population will include sequential examinees undergoing bidirectional endoscopy. The decision to perform same day sequential bidirectional endoscopy is of the examinee's caring gastroenterologist, and not part of the study. Only examinees \> 18 years will be eligible.

Brief summary: The investigators study aim is to determine whether there is a any advantage in starting with upper or lower endoscopy. The main study objective will be the amount of analgesia needed for sustaining the examinee's comfort during the exams. Secondary endpoints will rate of detection of significant pathologies, total time of procedure, examinee's tolerance, time to recovery and examinee's satisfaction.


Eligibility criteria: Inclusion Criteria:

* Age\> 18
* Same day bidirectional endoscopy

Exclusion Criteria:

* Prior failed endoscopy.
* Any major complication during previous endoscopy.
* Difficulty in communication with the patients.
* Psychiatric disease or mental retardation.

Primary outcomes:
measure: Dose of mephridine and midazolam
timeFrame: 1 year
Secondary outcomes:
measure: Time to recovery
timeFrame: 1 year
measure: Rate of significant findings
timeFrame: 1 year
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba medical center
Study officials:
affiliation: Sheba Medical Center
name: Dan Carter, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cho JH, Kim JH, Lee YC, Song SY, Lee SK. Comparison of procedural sequences in same-day bidirectional endoscopy without benzodiazepine and propofol sedation: starting at the bottom or the top. J Gastroenterol Hepatol. 2010 May;25(5):899-904. doi: 10.1111/j.1440-1746.2009.06157.x.
citation: Urquhart J, Eisen G, Faigel DO, Mattek N, Holub J, Lieberman DA. A closer look at same-day bidirectional endoscopy. Gastrointest Endosc. 2009 Feb;69(2):271-7. doi: 10.1016/j.gie.2008.04.063. Epub 2008 Aug 23.
citation: Hardwick RH, Armstrong CP. Synchronous upper and lower gastrointestinal endoscopy is an effective method of investigating iron-deficiency anaemia. Br J Surg. 1997 Dec;84(12):1725-8.
Clinical trial NCT03292926: A Novel Analgesia Technique for ACL Reconstruction
Official title: A Randomized Controlled Trial to Evaluate a Novel Analgesia Technique for ACL Reconstruction: Adductor Canal Block With an IPACK Versus Adductor Canal Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anterior Cruciate Ligament Injury
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2017-09-26
Enrollment: 78
Sex: ALL
Minimum age (years): 13
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A comparison of two anesthetic techniques-- the Adductor Canal Block (ACB) and the Adductor Canal Block with Infiltration of the interspace between the popliteal artery and the capsule of the posterior knee (ACB/IPACK)-- in patients undergoing bone-tendon-bone (BTB) anterior cruciate ligament (ACL) reconstruction.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing BTB ACL reconstruction with participating surgeon
* Age 13 or greater
* Planned use of regional anesthesia
* Ability to follow study protocol
* English speaking (secondary outcomes include questionnaires validated in English only)

Exclusion Criteria:

* Hepatic or renal insufficiency
* Younger than 13 years old
* Patients undergoing general anesthesia
* Allergy or intolerance to one of the study medications
* BMI \> 40
* Diabetes
* American Society of Anesthesiology (ASA) score IV
* Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
* Chronic opioid use (taking opioids for longer than 3 months, or daily morphine equivalent of \>5mg/day for one month)
* Non-English speaking

Primary outcomes:
measure: Pain While at Rest
timeFrame: 24 hours post-block administration
Secondary outcomes:
measure: Discharge Criteria
timeFrame: From 3 hours post-block administration on Post-operative day (POD) 0 until met discharge criteria, assessed up to 1 day
measure: Pain With Ambulation
timeFrame: 3 hours post-block administration on Post-operative day (POD) 0
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Jonathan Beathe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06331026: A Bioequivalence Study of Two Different PEG-rhGH Preparations.
Official title: A Randomized, Open-lable, Single-dose, 3-sequence, 3-period Crossover Bioequivalence Study of Two Different PEG-rhGH Preparations in Chinese Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pediatric Growth Hormone Deficiency (PGHD)
Lead sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-03-26
Enrollment: 87
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to investigate whether PEG-rhGH with new preparation is bioequivalent to PEG-rhGH with present preparation.


Eligibility criteria: Inclusion Criteria:

* Healthy male aged ≥18 years old and≤45 years old;
* The Body mass index (BMI): 19-26 kg/m2 (inclusive), and body weight ≥50 kg;
* Normal results of physical examination, vital signs, laboratory tests, 12 lead-ECG, chest X-ray, abdominal ultrasound, or non-clinical significance changes in the assessments above.

Exclusion Criteria:

* Subjects with a history of hypersensitivity reactions or clinically significant hypersensitivity reactions to drugs containing;
* Subjects with a clear history of disorders of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic system, etc., or other diseases deemed unsuitable for participation in the trials by the investigators;
* Subjects with severe infection, severe trauma, or major surgery prior to screening;
* Subjects who have received blood transfusions, had blood donors, or lost blood before screening;
* Subjects who have positive results of human immunodeficiency virus antibodies (HIV-Ab), or hepatitis B surface antigen (HBsAg), or hepatitis C virus antibodies (HCV-Ab), or syphilis specific antibodies (TPPA);
* Subjects who have participated in clinical trials for medication or medical device prior to screening;etc.

Primary outcomes:
measure: Pharmacokinetics (Peak Plasma Concentration (Cmax) ) of PEG-rhGH with present and new preparation
timeFrame: 0 hours -192 hours post-administration
measure: Pharmacokinetics (Area under the concentration-time curve from time zero to time infinity (AUC0-inf)) of PEG-rhGH with present and new preparation
timeFrame: 0 hours -192 hours post-administration
measure: Pharmacokinetics (Area under the concentration-time curve from time zero to the time of the last quantifiable (AUC0- last )) of PEG-rhGH with present and new preparation
timeFrame: 0 hours -192hours post-administration
Secondary outcomes:
measure: Safety and tolerability（Number of participants with treatment-related adverse events）
timeFrame: up to approximately 83 days
Other outcomes:
measure: Anti-drug antibody (Number of Participants with positive ADA)
timeFrame: 0 hours -192 hours post-administration
Locations:
city: Chengdu
country: China
facility: Chengdu Xinhua Hospital
state: Sichuan
Study officials:
References:
Clinical trial NCT05733026: Effect of Genetic and Epigenetic Factors on the Clinical Response and Toxicity to Doxorubicin Among Egyptian Breast Cancer Patients
Official title: Effect of Genetic and Epigenetic Factors on the Clinical Response and Toxicity to Doxorubicin Among Egyptian Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: Doxorubcin
Breast cancer
Cardiotoxicity
Gene polymorphism
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-02-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Metastatic and localized breast cancer patients treated with Doxorubicin

Brief summary: Recent advances in technologies, such as microarray and high-throughput sequencing, represented a deeper understanding of molecular biology, especially noncoding RNA (ncRNA). It was found that there are only \<2 % of the total genome sequence as protein-coding genes while at least 98 % of the genome are transcribed into ncRNA. In the past, non-protein-coding RNAs were known as "transcription noise," but now it is obvious that ncRNAs play a crucial regulatory role in cell differentiation and organism growth and metabolism.


Eligibility criteria: Inclusion Criteria:

* Metastatic and localized breast cancer patients treated with Doxorubicin among chemotherapeutic protocol.
* Measurable disease.
* Age of 18 years to 80 years.
* The women of childbearing age must use an effective contraception for the duration of the study.

Exclusion Criteria:

* Breast cancer patients who had undergone radiotherapy or chemotherapy.
* Pregnant and lactating females.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to chemotherapeutic agents used.
* Any other medical or psychiatric condition or severe or chronic laboratory abnormality making the inclusion of the patient in the study inappropriate in the opinion of the investigator.

Primary outcomes:
measure: Cardiotoxicity
timeFrame: 6 months
Secondary outcomes:
measure: Nephrotoxicity
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References: