louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02654626: A Multiple Ascending Dose Study of KBP-7072 in Healthy Subjects
Official title: A Randomized, Single-blind, Placebo-controlled, Sequential Parallel-Group and Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KBP-7072 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: KBP Biosciences
Sponsor class: INDUSTRY
First posted: 2016-01-13
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, single-blind, placebo-controlled, sequential parallel-group and multiple ascending dose (MAD) study to evaluate the safety, tolerability and pharmacokinetics of KBP 7072 in healthy subjects. The safety will be assessed at each dose level before progressing to the next higher dose.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female subject
* Are between the ages of 18 and 55 years (inclusive);
* Body mass index (BMI) of 19 to 30 kg/m2 inclusive and body weight not less than 50 kg.

Exclusion Criteria:

* Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity;
* Known or suspected malignancy;
* Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C (HCV) antibody;
* Positive pregnancy test result.

Primary outcomes:
measure: Safety and tolerability (i.e., number of participants with adverse events, abnormal vital signs, clinical laboratory findings, 12-lead ECGs and physical examinations) in healthy subjects
timeFrame: up to 17 days
Secondary outcomes:
measure: Area Under Curve (AUC) in healthy subjects
timeFrame: up to 10 days
Other outcomes:
Locations:
city: Secaucus
country: United States
facility: Frontage Laboratories, Inc.
state: New Jersey
Study officials:
References:
citation: Huband MD, Mendes RE, Pfaller MA, Lindley JM, Strand GJ, Benn VJ, Zhang J, Li L, Zhang M, Tan X, Liu Q, Flamm RK. In Vitro Activity of KBP-7072, a Novel Third-Generation Tetracycline, against 531 Recent Geographically Diverse and Molecularly Characterized Acinetobacter baumannii Species Complex Isolates. Antimicrob Agents Chemother. 2020 Apr 21;64(5):e02375-19. doi: 10.1128/AAC.02375-19. Print 2020 Apr 21.
Clinical trial NCT02069626: The Effect of Compression Time for Secure Stapling With a Linear Stapler in Laparoscopic Gastric Bypass Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bleeding of the Staple Line
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2014-02-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Bleeding from the staple line is a complication of linear stapling. After clamping, a short period after firing of the laparoscopic linear stapler is recommended. That is, the clinician should continue to press the tissue between the prongs of the device to achieve adequate hemostasis at the staple line. The significance of the waiting period for hemostasis at the staple line has not been empirically clarified in humans. In this study, the investigators compared the number of bleeding points use of the laparoscopic linear stapler. Consequently, the investigators assessed the effects of time after the firing of linear stapling in patients who underwent laparoscopic gastric bypass.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of morbid obesity
* Must be laparoscopic surgery

Exclusion Criteria:

* Usage of anti-coagulant
* Presence of impaired blood clotting

Primary outcomes:
measure: Number of the bleeding points at the staple line
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Turgut Özal medical center
Study officials:
References:
Clinical trial NCT04477226: Transvaginal Ultrasound As Predictors of Successful Induction of Labour
Official title: Pre-Induction Cervical Assessment Using Transvaginal Ultrasound Versus Bishop's Cervical Scoring in Term Pregnancies As Predictors of Successful Induction of Labour
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Induction of Labour
Lead sponsor: Universiti Kebangsaan Malaysia Medical Centre
Sponsor class: OTHER
First posted: 2020-07-20
Enrollment: 294
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who are admitted for induction of labour and fulfils the criteria will be recruited from Patient Admission Centre (PAC), antenatal ward, labour room

Brief summary: To compare the use of transvaginal ultrasound (TVUS) of cervix to the Bishops score prior to induction of labour in term pregnancies, and the ability to predict Caesarean delivery for failure to progress.

Detailed description: The aim of this prospective study is to compare the use of transvaginal ultrasound (TVUS) of cervix to the Bishops score prior to induction of labour in term pregnancies, and the ability to predict Caesarean delivery for failure to progress.

Eligibility criteria: Inclusion Criteria:

* Nulliparous or multipara
* Singleton live pregnancy
* Gestational age between 37 - 42 weeks
* Cephalic presentation
* Intact membranes
* Reactive cardiotocograph tracing
* Low risk pregnancy

Exclusion Criteria:

* Previous history of uterine surgery
* Low lying placenta, placenta praevia and vaginal bleeding
* Multiple pregnancy
* Preterm Prelabour rupture of membrane/ prelabour rupture of membranes
* Known allergy towards prostaglandins
* Intrauterine fetal death
* Known fetal anomaly
* Estimated fetal weight \>3.8kg by scan
* Grandmultiparity (more than 5)
* BMI \>40kg/m2
* Diabetes and hypertension on treatment
* Other medical illness on treatment

Primary outcomes:
measure: To determine the optimal cutoff points for cervical length measurement as predictor of successful labour induction
timeFrame: before induction of labour
Secondary outcomes:
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Universiti Kebangsaan Malaysia Medical Centre
Study officials:
affiliation: UKMMC
name: Kah Teik Chew
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00824226: Magnesium Treatment in Hypoparathyroidism
Official title: Effect of Magnesium Treatment on Plasma Calcium in Hypoparathyroid Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoparathyroidism
Keywords: primary hypoparathyroidism
secondary hypoparathyroidism
magnesium
Lead sponsor: University of Tartu
Sponsor class: OTHER
First posted: 2009-01-16
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: TREATMENT

Brief summary: Study hypothesis: supplementary magnesium may influence the blood calcium level in treated hypoparathyroid patients. Patients will be treated with supplementary magnesium (350 mg/day) for 3 weeks. Calcium and other relevant blood parameters will be measured before the treatment, at the end of treatment and 2 weeks after stopping treatment.


Eligibility criteria: Inclusion Criteria:

* primary or secondary hypoparathyroidism
* treatment with calcium plus vitamin D analogue
* ionized calcium 1,0-1,29 mmol/L
* magnesium level 0,7-1,05 mmol/L
* TSH 0.1- 10 imU/L

Exclusion Criteria:

* any other disease known to influence plasma Ca level
* pregnancy
* creatinine \> 150 microM/L
* patient has used supplementary magnesium within 2 previous months

Primary outcomes:
measure: Calcium level at the end of magnesium treatment compared to pretreatment level
timeFrame: 3 weeks
Secondary outcomes:
measure: Calcium level after stopping treatment compared to the level at the end of magnesium treatment
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Tartu
country: Estonia
facility: Tartu University Hospital
Study officials:
affiliation: University of Tartu, Institute of Physiology
name: Vallo Volke, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00543426: Fuzheng Huayu Tablets Against Posthepatitic Cirrhosis
Official title: Fuzheng Huayu Tablets Against Posthepatitic Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Posthepatitic Cirrhosis
Keywords: Fuzheng Huayu Tablets
Multicenter clinical study
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2007-10-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of the trial is adopted Fuzheng Huayu tablets against posthepatitic cirrhosis, and to build a standard evaluation system for efficacy of traditional Chinese medicine (TCM).

The second purpose is according to the international clinical guideline and the specialty of TCM to build a standard clinical trial regulation for traditional Chinese medicine.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of B Post hepatitic cirrhosis.
* Male or female patients between 18\~65 years old.
* Written informed consent.

Exclusion Criteria:

* Child-Pugh C above 12, or ALT \> 2×ULN, TBiL \> 2×ULN, or combined with hepatic encephacopathy, Obstinate ascites, bleeding tendency, hepato-renal syndrome, or primary liver cancer.
* Combined with severe heart, gallbladder, kidney, endocrine system, hemopoietic system or nervous system disease.
* Deformed man by the law.
* Pregnancy or breast feeding women, or unwilling to have contraception.
* Irritability body constitution, or irritability of the Fuzheng Huayu Capsules.
* Enter other trials lately one month.
* Other cause of cirrhosis.

Primary outcomes:
measure: the value of Child-Pugh and symptoms scale for Posthepatitic Cirrhosis
timeFrame: six months
Secondary outcomes:
measure: hepatic function; blood test; blood ammonia and blood sugar determination
timeFrame: six months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shuguang Hospital
Study officials:
affiliation: Shanghai Univercity of TCM
name: Zengzeng Cai, Ph.D
role: STUDY_DIRECTOR
References:
citation: Zhao CQ, Wu YQ, Xu LM. [Curative effects of Fuzheng Huayu capsules on hepatic fibrosis and the functional mechanisms: a review]. Zhong Xi Yi Jie He Xue Bao. 2006 Sep;4(5):467-72. doi: 10.3736/jcim20060505. Chinese.
citation: Liu P, Hu YY, Liu C, Xu LM, Liu CH, Sun KW, Hu DC, Yin YK, Zhou XQ, Wan MB, Cai X, Zhang ZQ, Ye J, Tang BZ, He J. [Multicenter clinical study about the action of Fuzheng Huayu Capsule against liver fibrosis with chronic hepatitis B]. Zhong Xi Yi Jie He Xue Bao. 2003 Jul;1(2):89-98, 102. doi: 10.3736/jcim20030204. Chinese.
citation: Zhang Q, Zhang WT, Wei JJ, Wang XB, Liu P. [Combined use of factor analysis and cluster analysis in classification of traditional Chinese medical syndromes in patients with posthepatitic cirrhosis]. Zhong Xi Yi Jie He Xue Bao. 2005 Jan;3(1):14-8. doi: 10.3736/jcim20050105. Chinese.
Clinical trial NCT02926326: The Effect of Azithromycin on BCT197 Exposure in Healthy Male Volunteers
Official title: An Open-label, Single-sequence Study to Evaluate the Effect of Azithromycin on BCT197 Exposure in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Interaction
Keywords: Healthy Male volunteers
Lead sponsor: Mereo BioPharma
Sponsor class: INDUSTRY
First posted: 2016-10-06
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An open-label, single-sequence study to evaluate the effect of azithromycin on BCT197 exposure in healthy male subjects.

Detailed description: This will be an open study conducted in healthy male subjects at a single centre. Each subject will participate in a screening visit and 2 study periods. At the first study period, all subjects will receive a single dose of BCT197 and at study period 2, all subjects will receive 3 daily doses of azithromycin and a single dose of BCT197.

Eligibility criteria: Inclusion Criteria

* Healthy male subjects.
* Non-smokers (including e-cigarettes).
* Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2.
* Willing to use highly effective barrier contraception methods.
* Male subjects must not donate sperm during the study.

Exclusion Criteria

* Any subjects with pre-existing active skin disease.
* Laboratory values at screening which are deemed to be clinically significant.
* Volunteers with abnormal liver function tests.
* 12 Lead ECG with QTcF \>450 msec.
* Allergy to any of BCT197 excipients.
* Known hypersensitivity or intolerance to azithromycin.
* Taking medications known to cause QTc prolongation.
* Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
* Any clinically significant illness within 30 days prior to study drug administration.
* Volunteers who, in the opinion of the Investigator, are unsuitable for participation in the study.

Primary outcomes:
measure: Maximum Measurable Plasma Concentration (Cmax) BCT197 in the presence and absence of Azithromycin.
timeFrame: Pre-dose to Day 15
measure: Area under the plasma concentration-time curve (AUC) BCT197 in the presence and absence of Azithromycin.
timeFrame: Pre-dose to Day 15
Secondary outcomes:
measure: The number of adverse events during administration of BCT197 alone and in the presence of Azithromycin.
timeFrame: Day 1 to Day 22
Other outcomes:
measure: Corrected QT interval of the electrocardiogram (QTc).
timeFrame: Pre-dose to Day 15
Locations:
city: Belfast
country: United Kingdom
facility: BioKinetic Europe Ltd
Study officials:
affiliation: Mereo BioPharma
name: Jacqueline Parkin, PhD FRCP
role: STUDY_DIRECTOR
References:
Clinical trial NCT05362526: High Flow vs Conventional Oxygen in Head and Neck Surgery
Official title: Prevention of Pulmonary Complications Using High Flow With Tracheostomy Interface vs Conventional Oxygen Therapy in Patients After Major Head and Neck Surgery: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease
COPD
Keywords: Head neck surgery
heated humidification
cool humidification
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Fisher and Paykel Healthcare
First posted: 2022-05-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients undergoing major head and neck surgery are at risk for postoperative pulmonary complications. The goal of this randomized clinical trial is to evaluate the effectiveness of high flow heated humidified oxygen at preventing postoperative pulmonary complications after major head and neck surgery, when compared to conventional oxygen therapy (aerosol cool mist).

Detailed description: Participants enrolled in this study are randomly assigned to receive either conventional oxygen therapy (aerosol cool mist) or heated humidified high flow oxygen via the trach after head and neck surgery. The study team then collects information regarding clinical outcomes to explore if there are differences between the two groups.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing major head and neck surgery that includes any neck dissection
* Major head and neck surgery is defined as having a mean length of stay of three or more days, based on the diagnosis \[14\]
* Surgery requires an elective tracheostomy for airway protection or laryngectomy tube in the case of total laryngectomy

Exclusion Criteria:

* \<18 years of age

Primary outcomes:
measure: Incidence of post-operative pulmonary complication
timeFrame: Day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Rui Fernandes, MD, DMD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05193526: COronaVirus Induced Acute Respiratory Disease Syndrome During PREGnancy
Official title: COronaVirus Induced Acute Respiratory Disease Syndrome During PREGnancy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acute Respiratory Distress Syndrome Related to SARS-CoV-2
Keywords: COVID-19,
Acute respiratory distress syndrome
Pregnancy
Preterm delivery
SARS-CoV-2
ICU
Critical Care
Mechanical ventilation
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
First posted: 2022-01-18
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women after 14 week of amenorrhoea with SARS-CoV-2 pneumonia requiring ICU admission for acute respiratory distress syndrome

Brief summary: Few data are available on the management of critically ill pregnant women with pneumonia related to SARS-CoV-2. In the absence of clear recommendations for the management of delivery, clinicians are faced with the risk of pregnancy continuation against the risk of premature birth. In these multicenter retrospective study, the investigators want to describe clinicians attitude on delivery management in pregnant women requiring invasive mechanical ventilation for acute respiratory distress syndrome related to SARS-CoV-2.

Two strategies will be compared on maternal, obstetric and neonatal outcomes:

* Wait strategy defined by no extraction within 24 hours of invasive venting
* Early strategy defined by extraction within 24 hours of invasive ventin


Eligibility criteria: 1. patient \> 18 years
2. Patient with SARS-CoV-2 pneumonia proven by RT-PCR
3. Hospitalization in an intensive care unit during pregnancy after 14 weeks' gestation
4. Need for ventilatory support including: oxygen therapy \> 6L/min and/or NIV and/or High Flow Oxygen and/or invasive mechanical ventilation +/- ECMO.

Exclusion Criteria:

* Patient's refusal to participate in this study

Primary outcomes:
measure: Compare two fetal extraction strategies: - Wait strategy defined by no extraction within 24 hours of invasive venting - Early strategy defined by extraction within 24 hours of invasive venting
timeFrame: 'Day 1.
Secondary outcomes:
measure: Number of patient requiring invasive mechanical ventilation with or without ECMO
timeFrame: 'Day 1.
measure: Number of patients receiving pharmacological treatments for the management of COVID: corticosteroids, antivirals, anti-IL6, anticoagulants, antibiotics
timeFrame: Day 1.
measure: Evolution over time of the number of patients admitted to the ICU in the participating
timeFrame: Day 1.
measure: Evolution over time of the number of patients admitted to the ICU in the participating
timeFrame: Day 1.
Other outcomes:
Locations:
city: Créteil
country: France
facility: 40 Avenue de Verdun
Study officials:
affiliation: Centre Hospitalier Intercommunal Créteil
name: Frederique SCHORTGEN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03320226: A Study of the Effect of Probiotics on Gastrointestinal Function During Pregnancy
Official title: A Study of the Effect of Probiotics on Gastrointestinal Function During Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Early
Nausea Gravidarum
Vomiting of Pregnancy
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2017-10-25
Enrollment: 39
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose as well as the aim of this project is to understand the effect of probiotics on gastrointestinal (GI) dysfunction such as nausea, vomiting, and constipation that are found during the first and second trimesters of pregnancy.

The primary objective of this project is to uncover whether probiotics have an effect on GI functional disorders.

The secondary objective is to identify the microbiota associated with probiotic intake.

The tested hypothesis is that gut microbiota influences the GI functions and may influence constipation, nausea, and vomiting during pregnancy.


Eligibility criteria: Inclusion Criteria:

* First and second trimester healthy or low risk pregnant women who report gastrointestinal disorders such as nausea, vomiting, and constipation

Definition of healthy or low risk pregnant women:

* Systolic blood pressure \< 140 mmHg and diastolic blood pressure \< 90 mmHg
* Hemoglobin ≥ 10.0 g/dL
* Have immunity against rubella (German measles)
* HIV negative
* Urine test shows no sign of kidney or urinary tract infection

  * 27 weeks 6 days gestation or less with confirmed fetal heart beat
  * Pregnant women age 18 and older

Exclusion Criteria:

* High risk pregnant women who have existing health conditions such as high blood pressure, Type 1 diabetes, HIV positive, or are infected with Hepatitis B, Syphilis, or other sexually transmitted diseases
* Pregnant women who have multiple gestations or a history of recurrent miscarriages (more than two consecutive miscarriages)
* Had prior bariatric surgery
* Conceived through IVF program
* Pregnant women who have had severe weight loss (more than 5 pounds) during pregnancy. \[Note: Mild weight loss (2-3 pounds) due to nausea, vomiting, or loss of appetite is considered normal.\]
* Medical history of irritable bowel syndrome or other non-pregnancy related GI dysfunction/disorder

Primary outcomes:
measure: Number of vomiting and nausea per day
timeFrame: 16 days following baseline fecal sample collection
Secondary outcomes:
measure: The relative quantity of gut bacteria at phylum, family, and species level when patients take or do not take Probiotic-10.
timeFrame: 16 days following baseline fecal sample collection
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis
state: California
Study officials:
References: