louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01076985: Special Investigation of Kaletra in Pregnant Women
Official title: Special Investigation of Kaletra in Pregnant Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Immunodeficiency Virus
Keywords: Human Immunodeficiency Virus
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2010-02-26
Enrollment: 24
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital

Brief summary: This non-interventional, post-marketing observational study was conducted to obtain safety data from the use of lopinavir/ritonavir (Kaletra), in clinical practice, in pregnant women and their children in Japan.


Eligibility criteria: Inclusion Criteria:

* All pregnant women who have received Kaletra for the treatment of HIV infection were eligible for this study

Exclusion Criteria:

* Contraindications according to the Package Insert:

  * Patients with a history of hypersensitivity to any ingredient of Kaletra
  * Patients who are receiving pimozide, cisapride, ergotamine tartrate, dihydroergotamine mesylate, ergometrine maleate, methylergometrine maleate, midazolam, triazolam, vardenafil hydrochloride hydrate, boriconazol

Primary outcomes:
measure: Number of Patients With Adverse Drug Reactions (ADRs)
timeFrame: During pregnancy and for one year after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Site Reference ID/Investigator# 35862
city: Okayama
country: Japan
facility: Site Reference ID/Investigator# 35863
city: Osaka
country: Japan
facility: Site Reference ID/Investigator# 35864
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 35865
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 5326
Study officials:
affiliation: Abbott Japan Co.,Ltd
name: Toshiro Maeda
role: STUDY_DIRECTOR
References:
Clinical trial NCT01375985: Safety Study of Single Administration Intravenous Treatment for Influenza
Official title: A Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of AVI-7100 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Influenza
Lead sponsor: Sarepta Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2011-06-20
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to characterize the safety and pharmacology of single administrations of AVI-7100, a candidate treatment for influenza.

Detailed description: Influenza A, a member of the Orthomyxoviridae family, is composed of a negative-sense,single-stranded and segmented ribonucleic acid (RNA) genome. An urgent need exists for new forms of treatment for influenza A based on (a) the known propensity of this virus to undergo both continuous low-level antigenic drift and less frequent but unpredictable major antigenic shift leading to pandemic disease, (b) the clear failure of vaccination, even when strains are reasonably matched, to prevent influenza-related illness in a significant proportion of vaccine recipients, and (c) the increased frequency of resistance to approved forms of therapy for influenza (eg, the adamantane derivatives and, more recently, the NA inhibitor, oseltamivir). AVI-7100 is an experimental phosphorodiamidate morpholino antisense oligomers with positive charges on selected subunits (PMOplus™). AVI-7100 specifically targets viral messenger RNA sequences. The present study is designed to characterize the safety, tolerability and pharmacokinetics of escalating single-administration doses of AVI-7100 in healthy human subjects.

Eligibility criteria: Inclusion Criteria:

* Male or female and between the ages of 18 and 50 years in good general health
* Volunteers must be willing to use barrier methods of contraception or be of non-childbearing potential
* Volunteers must be willing to undergo a urine screen for drugs of abuse

Exclusion Criteria:

* Pregnancy or breastfeeding.
* Any clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis
* Positive test for human immunodeficiency virus, hepatitis B or hepatitis C or known history of HIV infection

Primary outcomes:
measure: Number of subjects experiencing adverse events
timeFrame: 28 days
Secondary outcomes:
measure: Plasma drug concentration
timeFrame: 28 days
measure: Urine drug concentration
timeFrame: 28 days
Other outcomes:
Locations:
city: Madison
country: United States
facility: Covance Clinical Research Unit
state: Wisconsin
Study officials:
affiliation: Covance Clinical Research Unit
name: Christine Hale, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sarepta Therapeutics, Inc.
name: Alison Heald, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03342885: Sleep Ergonomics in Low Back Pain
Official title: The Effect of Sleep Ergonomics on Pain Low Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Keywords: Low Back Pain
Sleep ergonomics
Lead sponsor: Central Finland Hospital District
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 120
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 aim of this study is to investigate the effect of sleep ergonomics guidance given by physiotherapist on pain and disability in patients with low back pain. In this randomized controlled trial participants are assigned either into the intervention or the control group. The intervention group will receive detailed instruction on sleeping ergonomics whereas the control group will only be instructed to avoid painful sleeping posture. The initial hypothesis is that in the intervention group pain and disability will decrease more compared to the control group.


Eligibility criteria: Inclusion Criteria:

* Low Back Pain
* Pain during sleep or

Exclusion Criteria:

* Fibromyalgia
* Inflammatory rheumatic disease
* Severe depression or other psychiatric diagnosis
* Previously received specific guidance in sleep ergonomics

Primary outcomes:
measure: Pain Visual Analog Scale (VAS)
timeFrame: Change from baseline to 12 month follow-up
measure: Oswestry Disability Index (ODI) score
timeFrame: Change from baseline to 12 month follow-up
Secondary outcomes:
measure: Reported amount of sleep
timeFrame: Change from baseline to 12 month follow-up
measure: Number of sick leave days
timeFrame: Change from baseline to 12 month follow-up
Other outcomes:
Locations:
city: Jyväskylä
country: Finland
facility: Central Finland Central Hospital
Study officials:
affiliation: Central Finland Hospital District
name: Jari Ylinen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05564585: Effect Kinesio Taping on Acute-onset Muscle Soreness and Calf Muscle Extensibility Among Endurance Athletes
Official title: Immediate Effect oF Kinesio Taping on Calf Soreness and Extensibility Among Endurance Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Soreness
Keywords: Kinesio tape
Sham tape
Ankle dorsiflexion
Range of motion
Pain
Muscle soreness
Lead sponsor: King Saud University
Sponsor class: OTHER
Collaborators: name: Hamdard University
First posted: 2022-10-03
Enrollment: 55
Sex: ALL
Minimum age (years): 10
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In recent years, athletes have frequently utilized Kinesio tape (KT) to enhance their performance. Despite widespread use, data regarding its efficacy and mechanism of action is lacking among healthy endurance athletes. This study aims to determine the effect of KT application on acute-onset muscle soreness and the extensibility of the calf muscles in endurance athletes.

Detailed description: The study followed a single-blinded one-arm crossover repeated-measures randomized controlled design and included fifty-five endurance athletes (mean age, 16.40±2.69) from different stadia in Delhi, India. Outcome measures, including the ankle dorsiflexion range of motion (ADFROM), were measured using a universal goniometer before, immediately after application of either KT or Sham tape, and after treadmill running. However, the pain due to acute-onset muscle soreness was measured using a numeric pain rating scale (NPRS) immediately, 10 min, and 30 min after treadmill running.

Eligibility criteria: Inclusion Criteria:

* Endurance athletes, including Cyclists, Badminton players, Long-distance runners
* Both males and females aged between 10-20 years
* Having BMI within the normal range (19-25)
* Cooperation in the study

Exclusion Criteria:

* Other than endurance athletes
* Aged less than Ten and more than 20 years
* BMI fall beyond the normal range, either underweight or overweight
* Musculoskeletal injuries, skin problems
* Non-cooperation in the study

Primary outcomes:
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: 1 Day
measure: Range of Motion
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Rehabilitation Research Chair
Study officials:
affiliation: King Saud University
name: AMIR IQBAL
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04359485: New Score for Pseudo- Acanthosis Nigricans
Official title: Use Of A Novel Quantitative Tool For Evaluation of Pseudo- Acanthosis Nigricans: Acanthosis Nigricans Area And Severity Index
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pseudo Acanthosis Nigricans
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Each side of the neck pseudo acanthosis nigricans was randomized in to either receiving glycolic acid peel or saline. Evaluation was done at baseline and after 3 sessions 2 weeks apart by percentage involvement and by ANASI score


Eligibility criteria: Inclusion Criteria:

* mild to moderate severity
* age \> 18 years old

Exclusion Criteria:

* Pregnant and lactating patients,
* patients with systemic diseases as connective tissue disease, diabetes,
* skin infection
* use of immunosuppressive drugs
* Susceptibility for post peel hazards as hyperpigmentation
* scarring and keloidal tendency

Primary outcomes:
measure: Percentage involvement
timeFrame: 6 months to 1 year
measure: Acanthosis Nigricans Area and Severity Index score
timeFrame: 6 months to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr El Ainy university hospital, Faulty of medicine,Cairo university
Study officials:
References:
Clinical trial NCT02106585: Study of Safety, Tolerability and Pharmacokinetics of Single Oral JTT-251 Doses in Healthy and Type 2 Diabetic Subjects
Official title: Phase 1, Randomized, Single-blind, Placebo-controlled Dose Escalation Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of JTT-251 Single Oral Doses in Healthy Subjects (Part Ia) and in Type 2 Diabetic Subjects (Part Ib) and Randomized, Open-label, Crossover Study Evaluating Effect of Food on PK in Healthy Subjects (Part II)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus
Keywords: Safety
Tolerability
Pharmacokinetics
Food-effect
Diabetes
Lead sponsor: Akros Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2014-04-08
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability, and PK (Pharmacokinetics) of single oral doses of JTT-251 in healthy and type 2 diabetes mellitus subjects and to evaluate the effect of food on the PK of JTT-251 in healthy subjects.


Eligibility criteria: Inclusion Criteria:

Healthy Subject Cohorts:

* Healthy male or female subjects
* Body Mass Index (BMI) between 19.0 and 31.0 kg/m2 (inclusive)

Type 2 Diabetic Subject Cohorts:

* Male or female Type 2 diabetic subjects diagnosed for at least 3 months
* BMI between 25 and 40 kg/m2 (inclusive)
* Have a glycosylated hemoglobin (HbA1c) of \>6.5% to ≤10.9% (inclusive) if treatment naïve with respect to hypoglycemic agents OR \>6.5% to ≤10.0% (inclusive) if treated with metformin

Exclusion Criteria:

Healthy Subject Cohorts:

* Known clinically relevant history or presence of significant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, metabolic, and dermatological or connective tissue disease
* Subjects with a systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>90 mmHg

Type 2 Diabetic Subject Cohorts:

* Subjects with a known medical history or presence of type 1 diabetes mellitus
* Subjects with known medical history of acute metabolic diabetic complications
* Subjects with uncontrolled hypertension (systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>95 mmHg with documented ongoing treatment)

Primary outcomes:
measure: Number of subjects with adverse events
timeFrame: 1 week
measure: Vital signs and 12 lead ECGs
timeFrame: 1 week
measure: Cmax (maximum concentration)
timeFrame: 1 week
measure: t1/2 (elimination half-life)
timeFrame: 1 week
measure: AUC (area under the concentration-time curve)
timeFrame: 1 week
measure: fe(total) (fraction of systemically available drug excreted into the urine over entire collection interval)
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
state: Florida
Study officials:
affiliation: Akros Pharma Inc.
name: Hideyuki Yamamoto
role: STUDY_CHAIR
References:
Clinical trial NCT01975285: Efficacy of Popliteal Nerve Blocks With and Without Dexamethasone on the Duration of Analgesia for Foot & Ankle Surgery
Official title: Prospective Randomized Double Blind Study to Evaluate the Efficacy of Popliteal Nerve Blocks With and Without Dexamethasone on the Duration of Analgesia for Foot & Ankle Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Foot and Ankle Procedures
Keywords: Pain management
Postoperative opioid requirements
Perioperative outcomes
Dexamethasone
Anesthetic adjuvant
Analgesic adjuvant
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2013-11-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this research study to evaluate the effects of dexamethasone as an addition to peripheral nerve block (Put the nerve to sleep with Bupivacaine a numbing medication) on length of pain relief (analgesia), postoperative narcotic (opioids) requirements, pain scores, and patient satisfaction after foot and ankle procedures.


Eligibility criteria: Inclusion Criteria:

* 60 patients (30 per group) undergoing foot and ankle procedures
* Willingness and ability to sign an informed consent document
* No allergies to anesthetic or analgesic medications
* American Society of Anesthesiologists (ASA)physical status Class I - III
* Aged 18-90 years,either sex

Exclusion Criteria:

* Refusal to participate in the study
* Age\<18 or\> 90 years -
* Contraindications to regional blockage including but not limited to:
* Patient refusal to regional blockade
* Infection at the site of needle insertion
* Systemic infection
* Bleeding diathesis or coagulopathy

Primary outcomes:
measure: Postoperative Pain
timeFrame: 3 days
Secondary outcomes:
measure: Opioid Consumption
timeFrame: 3 days
measure: Length of Analgesia
timeFrame: 3 days
measure: Patient Satisfaction With Regional Nerve Block
timeFrame: 3 days
measure: Patient Satisfaction With Pain Management
timeFrame: 3 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Roya Yumul, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05223985: EPC Performance Investigation for StereoElectroEncephaloGraphy
Official title: EPISEEG - EPC Performance Investigation for StereoElectroEncephaloGraphy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Epilepsy
Lead sponsor: Alcis
Sponsor class: INDUSTRY
First posted: 2022-02-04
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The patient treated by Depth Coagulation Electrode is drug-resistant epilepsies patient.

Brief summary: The objective of this multicentre study is to collect preoperative, intra operative, early, short, intermediate and mid-term(one years) on the related clinical complications and functional outcomes of market-approved Alcis products to demonstrate safety and performance of these devices in a real-world setting.

Detailed description: Outcome data collected from this study will provide the basis for Post-Market Surveillance (PMS) reporting, Clinical Study Report (CSR), Clinical Evaluation Report (CER) on Alcis devices and support peer-reviewed publications on products performance and safety.

Eligibility criteria: Inclusion Criteria:

* To be included, patients must be:
* 18 months to 65 years
* Patient with drug-resistant and disabling focal epilepsy
* Informed and willing to sign an informed consent form approved by EC / For minors: if one of the parents cannot consent within the timeframe provided by the protocol, then only one parent's signature is required
* Affiliation to the social security or foreign regime recognized in France
* For prospective inclusion: Patient considered for SEEG exploration as part of pre-surgical assessment of epilepsy
* For ambispective inclusion:

  * Must have undergone an SEEG exploration with one ALCIS device before the date of the initiation visit
  * Follow-up visits (at least 12-month) must be prospective
  * Must have complete information available for each completed visit (demographics, preoperative information, implantation information, device details) \*.

Exclusion Criteria:

* • Not able to comply with the study procedures based on the judgment of the assessor (e.g. cannot comprehend study questions, inability to keep scheduled assessment times)

  * Any medical condition that could impact the study at investigator's discretion (e.g. allergy...)
  * Pregnant women (contraindication to SEEG exploration)
  * Adult subject to legal protection measure
  * Skull thickness inferior at 2 mm

Primary outcomes:
measure: Signal quality
timeFrame: through study completion, an average of 10 days".
measure: Modification of Electroencephalography trace post-coagulation
timeFrame: through study completion, an average of 1 hours".
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Pôle Investigation - Fondation Adolphe de Rothschild
state: Ile De France
city: Marseille
country: France
facility: Centre d'Investigation Clinique : Equipe Timone Adultes CPCET
Study officials:
References:
Clinical trial NCT03686085: Vaginal Dinoprostone Administration Prior to a T380A Intrauterine Device Insertion in Nulliparous Women.
Official title: Effects of Prophylactic Vaginal Dinoprostone Administration Prior to a T380A Intrauterine Device Insertion in Nulliparous Women.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Intrauterine Device
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-09-26
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To investigate whether vaginal dinoprostone administered before intrauterine device (IUD) insertion reduces failed insertions, insertion-related complications and pain in nulliparous women.

Detailed description: Women may experience pain and technical difﬁculties may be encountered when insertion of an intrauterine device (IUD) is attempted through a narrow cervical canal.IUD insertion- related complications and side effects are more common among women who had never delivered vaginally.n American College of Obstetricians and Gynecologists committee opinion encourages providers to use IUDs as a ﬁrst line of contraception in nulliparous women.

Eligibility criteria: Inclusion Criteria:

* Nulliparous women aged over 18 years of age requesting a copper IUD for contraception, had a negative pregnancy test.

Exclusion Criteria:

* • a prior pregnancy greater than 20 weeks of duration

  * currently pregnant or were pregnant within 6 weeks of study entry
  * had a prior attempted or successful IUD insertion
  * had a history of a cervical procedure such as cone biopsy, Loop electrosurgical excision procedure, or cryotherapy
  * any World Health Organization Medical Eligibility Criteria category 3 or 4 precaution to an IUD
  * active vaginitis or cervicitis
  * undiagnosed abnormal uterine bleeding
  * pelvic inﬂammatory disease within the last 3 months
  * ﬁbroids or other uterine abnormalities distorting the uterine cavity
  * contraindication to dinoprostone.

Primary outcomes:
measure: Provider ease of insertion
timeFrame: 5 minutes
Secondary outcomes:
measure: the difference in the pain intensity scores between the study groups
timeFrame: 5 minutes
measure: insertion time
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Medicine Cairo University
Study officials:
affiliation: Cairo University
name: AHMED SAMY, MD
role: PRINCIPAL_INVESTIGATOR
References: