louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01022424: A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (2) [Extension of Study 156-05-002]
Official title: A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (2) [Extension of Study 156-05-002]
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Autosomal Dominant Polycystic Kidney Disease
Keywords: ADPKD
Tolvaptan
OPC-41061
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2009-12-01
Enrollment: 13
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: ADPKD patients who were enrolled in Study 156-05-002 will receive repeated oral administration of OPC-41061 at doses of 15 mg twice daily (morning and evening). Administration will be continued until the time of manufacturing and distribution approval of OPC-41061 for ADPKD in Japan.


Eligibility criteria: Inclusion Criteria:

* Patients who completed 3-year repeated administrations and the follow-up observation or those who were withdrawn from the study due to reasons other than occurrence of adverse events (based on the judgment of either the subject or the investigator/subinvestigator) in the preceding study (156-05-002)
* Patients in whom adverse events occurring in study 156-05-002 were resolved or became stable and do not require further follow-up.

Exclusion Criteria:

* Patients with eGFR of less than 15 mL/min/1.73 m2
* Patients with any of the following complications:

  * Uncontrolled hypertension
  * Serious cardiovascular disease (eg. heart failure) or hepatic disease (eg. cirrhosis)
* Patients with any of the following complications or history thereof:

  * Clinically significant drug allergies (anaphylaxis) or hypersensitivity (especially, hypersensitivity to benzazepine derivatives or suspected hypersensitivity
  * Inability to personally give consent due to a mental illness

Primary outcomes:
measure: Total Kidney Volume
timeFrame: Baseline, Week 48, 96, 144, and 192
measure: Renal Function Test (eGFR)
timeFrame: Baseline, Week 48, 96, 144, and 192
Secondary outcomes:
Other outcomes:
Locations:
city: Kanto Region
country: Japan
Study officials:
References:
Clinical trial NCT03844724: Drug-eluting PTA Balloon Dilatation Catheter in the Treatment of Peripheral Artery Stenosis or Occlusion
Official title: Safety and Efficacy of ZENFlow™ Drug-eluting PTA Balloon Dilatation Catheter in the Treatment of Iliac, Femoral and Popliteal Artery Stenosis or Occlusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Iliac Artery Stenosis
Femoral Artery Stenosis
Popliteal Artery Stenosis
Iliac Artery Occlusion
Femoral Artery Occlusion
Popliteal Artery Occlusion
Keywords: Peripheral Arterial Disease
Drug-eluting PTA Balloon Dilatation Catheter
Late Lumen Loss（6 months）
Lead sponsor: Zhejiang Zylox Medical Device Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-02-18
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinical study on safety and efficacy of ZENFlow™ drug-eluting PTA balloon dilatation catheter in the treatment of iliac, femoral and popliteal artery stenosis or occlusion

Detailed description: The purpose of this study was to evaluate the safety and efficacy of ZENFlow™ drug-eluting PTA balloon dilatation catheter (paclitaxel 3±1 μg/mm2 balloon surface area) in the treatment of iliac artery, femoral artery and popliteal stenosis or occlusive lesions compared with conventional PTA balloon dilatation catheter.

Eligibility criteria: Inclusion Criteria:

* Aged from 18 to 85 years old, male or female
* Subject's target lesions were stenosis and/or occlusion
* Subjects were able to understand the purpose of the study, demonstrate full compliance with the program and sign informed consent

Exclusion Criteria:

* Pregnant woman or who's pregnancy test is positive
* Lactation period woman or woman/man with fertility plan

Primary outcomes:
measure: Late Lumen Loss at 6 months after operation
timeFrame: 6 months
Secondary outcomes:
measure: The incidence of major adverse events
timeFrame: 12 months
measure: Adverse Event
timeFrame: Preoperative、Intraoperative、up to 1 month、3 months、6 months、9 months、12 months
Other outcomes:
Locations:
Study officials:
affiliation: Peking Union Medical College Hospital
name: Changwei Liu
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ni L, Ye W, Zhang L, Jin X, Shu C, Jiang JS, Yang M, Wu DM, Li M, Yu GF, Yang J, Huang JH, Wang XB, Li XQ, Jiang WL, Wu ZQ, Liu CW. A Multicenter Randomized Trial Assessing ZENFlow Carrier-Free Drug-Coated Balloon for the Treatment of Femoropopliteal Artery Lesions. Front Cardiovasc Med. 2022 Mar 15;9:821672. doi: 10.3389/fcvm.2022.821672. eCollection 2022.
Clinical trial NCT00046124: Organophosphate Pesticides and Human Reproductive Health
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fecundability
Spermatazoa Disorders
Menstruation Disorders
Endocrine Dysfunction
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
First posted: 2002-09-23
Sex: ALL
Minimum age (years): 20
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: This prospective cohort study assesses the effects of exposure to organophosphate (OP) pesticides on adverse reproductive outcomes in both male and female agricultural workers in China. We will enroll women and their spouses, who are attempting to become pregnant, and observe reproductive endpoints including (1) semen parameters (concentration, total count, motility, progression and morphology), (2) menstrual disorders (oligomenorrhea, amenorrhea, polymenorrhea, intermenstrual bleeding, prolonged menstrual bleeding, dysmenorrhea, and irregular menstruation); (3) alterations in hormone patterns including reduced estrogen excretion (REE), anovulation, abnormal luteal phase (ALP), and abnormal follicular phase (AFP) in women and abnormalities of LH, FSH, TSH, SHBG, inhibin-B and testosterone in men; (4) fecundability; and (5) pregnancy outcomes including spontaneous abortion, preterm delivery, low birth weight, and intrauterine growth retardation.


Eligibility criteria: Inclusion Criteria:

* it must be the first marriage for both the woman and her husband and they must currently live in the study area;
* the female's age must range from 20 to 34 years;
* the couple has no plan to leave the study area in which they live for the next two years.

Exclusion Criteria:

* those who are currently pregnant;
* those who have tried unsuccessfully to get pregnant for at least 1 year;
* those who are current or former smokers;
* those who plan to move in the coming year.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Anqing City
country: China
facility: Anhui Medical University
state: Anhui
Study officials:
References:
Clinical trial NCT03185624: Effectiveness of Rifaximin on Preventing Postoperative Recurrence in Crohn's Disease
Official title: Effectiveness of Rifaximin on Preventing Postoperative Endoscopic Recurrence in Crohn's Disease Patients Without Risk Factor for Recurrence: A Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Crohn Disease
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital, Sun Yat-Sen University
name: Peking Union Medical College Hospital
name: Xijing Hospital
name: Shanghai 10th People's Hospital
name: RenJi Hospital
name: Sir Run Run Shaw Hospital
First posted: 2017-06-14
Enrollment: 80
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: PREVENTION

Brief summary: Some studies have shown that rifaximin is effective in the management of Crohn's Disease. Meanwhile, its adverse effect is tolerable. But no study has been conducted to assess its effect on preventing postoperative recurrence. Thus, we conduct a randomised controlled study to assess the effect of rifaximin on preventing postoperative endoscopic recurrence in Crohn's disease. The primary endpoint is the rate of endoscopic recurrence at 6 months.


Eligibility criteria: Inclusion Criteria:

1. Consecutive patients with Crohn's disease undergoing intestinal resection of all macroscopic diseased bowel, with an endoscopically accessible ileocolic anastomosis;
2. Enrolled patients without risk factor for the development of postoperative recurrence including penetrating disease behaviour, prior bowel resection, and active smoking.

Exclusion Criteria:

1. Severe comorbidities;
2. With a stoma;
3. With malignancy;
4. Pregnancy;
5. With contraindication of using rifaximin.

Primary outcomes:
measure: difference of incidence of endoscopic recurrence
timeFrame: 6 months after surgery
Secondary outcomes:
measure: Adverse effect
timeFrame: 6 months after surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT00943124: MK0524B Bioequivalence Study (0524B-070)
Official title: An Open-Label, Definitive Bioequivalence Study to Compare the Pharmacokinetics of the Simvastatin, Nicotinic Acid, and MK0524 (Laropiprant) Components of a Formulation of MK0524B With That of Zocor™ and MK0524A Tablets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dyslipidemia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-07-22
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will evaluate:

1. the bioequivalence of simvastatin and simvastatin acid following dose of simvastatin (ZOCOR™) given together with one tablet of MK0524A or as a component of the triple combination tablet MK0524B.
2. the bioequivalence of laropiprant and ER niacin when administered as the triple combination tablet MK0524B or as the double combination tablet MK0524A given together with simvastatin.


Eligibility criteria: Inclusion Criteria:

* Subject is in good health
* Subject is a nonsmoker
* Subject is willing to follow the study guidelines

Exclusion Criteria:

* Subject has or has a history of any illness that might confound the results of the study or make participation in the study unsafe for the subject

Primary outcomes:
measure: Plasma Area Under the Curve (AUC(0 to 48hr)) for Simvastatin Acid
timeFrame: Through 48 Hours Post Dose
measure: Peak Plasma Concentration (Cmax) of Simvastatin Acid
timeFrame: 48 Hours Post Dose
measure: Plasma Area Under the Curve (AUC(0 to 48 Hour)) for Simvastatin
timeFrame: Through 48 Hours Post Dose
measure: Peak Plasma Concentration (Cmax) of Simvastatin
timeFrame: 48 Hours Post Dose
measure: Plasma Area Under the Curve (AUC(0 to Infinity)) for Laropiprant
timeFrame: 48 Hours Post Dose
measure: Peak Plasma Concentration (Cmax) of Laropiprant
timeFrame: 48 Hours Post Dose
measure: Peak Plasma Concentration (Cmax) of Nicotinuric Acid
timeFrame: 24 Hours Post Dose
measure: Total Urinary Excretion of Niacin and Its Metabolites
timeFrame: 96 Hours Post Dose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04715724: Comparison of Baby Dolls for Teaching Newborn Positioning and Attachment
Official title: Evaluation and Comparison of Baby Dolls for Teaching Newborn Positioning and Attachment in a Clinical Lactation Telesimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Patient Simulation
High Fidelity Simulation Training
Lead sponsor: LiquidGoldConcept
Sponsor class: INDUSTRY
Collaborators: name: University of Michigan
First posted: 2021-01-20
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All participants will evaluate the Newborn Oral Assessment and Latch Simulator (NORALSim) and one of two other baby dolls: 1) a cloth doll with a puppet-style head where the user can control the opening and closing of the mouth, and 2) a rigid, plastic doll with a static open mouth. The order of presentation of the dolls between the two back-to-back simulations and the second baby doll will be randomized.
Primary purpose: OTHER

Brief summary: In this baby doll comparison study, clinical lactation specialists will complete two back-to-back video-based simulations (telesimulations) focused on newborn positioning and attachment. Study participants will interact with a standardized patient educator (SP) wearing the Lactation Simulation Model and using two baby dolls in a randomized order.

Detailed description: Identifying signs of effective newborn positioning and attachment is an essential skill for maternal-child care providers. No study has evaluated the effectiveness of commonly used baby dolls for teaching this skill. In this comparison study, clinical lactation specialists will be randomly assigned two baby dolls to evaluate in two back-to-back video-based simulations (telesimulations) with a standardized patient wearing the LiquidGoldConcept Lactation Simulation Model. Participants will complete a novel competency assessment using 3-second video clips to show specific components of positioning and attachment and evaluating whether any correction is needed and why or why not.

Eligibility criteria: Inclusion Criteria:

* Received IBCLC, CLC, FABM, or similar certification in clinical lactation
* At least 2 years professional experience with breastfeeding patients
* Work with lactating patients/clients at least monthly
* Work with positioning and attachment at least weekly

Exclusion Criteria:

* n/a

Primary outcomes:
measure: Technical Skills Confirmation
timeFrame: Day 1
Secondary outcomes:
measure: Relative realism of baby doll
timeFrame: Day 1
measure: Satisfaction with baby dolls
timeFrame: Day 1
Other outcomes:
Locations:
city: Ypsilanti
country: United States
facility: LiquidGoldConcept
state: Michigan
Study officials:
References:
Clinical trial NCT03474224: Hemodynamic Optimization During Major Urological Surgery
Official title: Correlation Between IN-TArget Time for Mean Arterial Pressure and Stroke Volume During Major Urological Surgery and Tissue Perfusion: the INTAT Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemodynamic Instability
Keywords: stroke volume
goal directed therapy
major urological surgery
mean arterial pressure
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2018-03-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled for major urological surgery who met the above mentioned inclusion criteria will be enrolled. All patients will belong the only study group in which a target-based hemodynamic protocol will be applied

Brief summary: In this prospective observational study investigators aim to seek for any possible correlation between the venous to arterial carbon dioxide difference (pCO2 gap) at the end of surgery and the percentage of time spent above a predefined threshold of stroke volume (SV) andn mean arterial pressure (MAP).

Detailed description: During major urological surgery (i.e. cistectomy) investigators will use a minimally invasive hemodynamic monitoring system (Flotrac - Vigileo, Edwards ) to guide fluid therapy and vasopressors administration. More specifically stroke volume target will be defined as the maximum SV after a series of fluid boluses, with a 10% tolerance. MAP was considered adequate if above 65 mmHg. After the induction of anesthesia, then each hour during surgery until the end of surgical procedure investigators will assess the time of adherence to the hemodynamic protocol (in terms of both SV and MAP) and the correspondent pCO2 gap. Investigators expect to find an inverse proportionality between the two parameters explored.

Eligibility criteria: Inclusion Criteria:

* patients scheduled for major urological surgery
* ASA 1-2-3

Exclusion Criteria:

* pregnancy
* obesity with a BMI \> 35
* controindications to central venous catheter positioning
* end-stage renal disease

Primary outcomes:
measure: Correlation between the time-in target of MAP and the pCO2 gap at the end of surgery
timeFrame: an average of 8 hours
measure: Correlation between the time-in target of SV and the pCO2 gap at the end of surgery
timeFrame: an average of 8 hours
Secondary outcomes:
measure: incidence of postoperative overall complications
timeFrame: up to 30 days
measure: duration of hospitalization
timeFrame: an average of 2 weeks
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Andrea Russo
Study officials:
affiliation: Department of Anesthesiology
name: Andrea Russo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05850624: Virtual Reality Animation and Ice Massage on The Hoku Point
Official title: Effect of Virtual Reality Animation and Ice Massage on The Hoku Point on Labor Pain, Duration of Labor, and Satisfaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Keywords: birth pain,
satisfaction
ice massage
virtual reality
Lead sponsor: Kastamonu University
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 94
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this study was to compare the effects of ice massage and virtual reality animation on labor pain, duration, and satisfaction with delivery.

The main questions aims to answer are:

H1 There are differences between Ice massage group and/or virtual reality animation groups and the control group in women's' labor pain.

H2 There are differences between Ice massage group and/or virtual reality animation groups and the control group in women's' labor duration.

H3 There are differences between Ice massage group and/or virtual reality animation groups and the control group in women's' satisfaction.

This randomized controlled trial (n = 94) includes three arms. Two intervention groups (ice massage (IMG); virtual reality animation (VRA)) and one control group, (CG). Personal information form, and Visual Analog Scale (VAS) and Birth Satisfaction Scale will used to collect data. Frequency and percentage calculations, Mann Whitney U, Kruskal Wallis test, chi-square test, Tukey's honestly significant difference test, and will used for data analysis.


Eligibility criteria: Inclusion Criteria:

* Term primiparous and singleton pregnancies,
* Longitudinal and vertex position of the fetus,
* Body Mass Index (BMI) below 30,
* cervical dilatation of 0-3 cm,
* who agreed to participate in the study

Exclusion Criteria:

* applying pharmacological intervention during labor,
* having a risky pregnancy,
* want to withdraw from the study,
* having ice allergy,
* being visually impaired.

Primary outcomes:
measure: labor pain
timeFrame: "Change from Baseline cervical dilatation 0-3 cm (duration can change 8-9 hours)
measure: labor duration
timeFrame: "Change from Baseline cervical dilatation 6-8 cm(duration can change 4-8 hours)
measure: labor duration
timeFrame: hour of latent phase ( duration can change 8-9 hour)
measure: labor duration
timeFrame: hour of placental expulsion (duration can change 10 minutes to 30 minutes)
measure: birth satisfaction
timeFrame: postpartum period up to 24 hours
measure: labor pain
timeFrame: active phase up to 20 hours
measure: labor duration
timeFrame: hour of total delivery (can change 14-18 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Kastamonu
country: Turkey
facility: Kastamonu University
Study officials:
References:
Clinical trial NCT05299424: A Study of CM336 in Patients With Relapsed or Refractory Multiple Myeloma
Official title: A Multi-center, Open-label, Phase 1/2 Clinical Study of CM336 Injection in Patients With Relapsed or Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Multiple Myeloma
Lead sponsor: Keymed Biosciences Co.Ltd
Sponsor class: INDUSTRY
First posted: 2022-03-29
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a multi-center, open-label, Phase 1/2 study in China to evaluate the safety, tolerability, efficacy, pharmacokinetics, pharmacodynamics and immunogenicity of CM336 in patients with relapsed or refractory multiple myeloma.

This study consists of a dose escalation part (Phase 1) and a dose extension part (Phase 2 ).

The safety and tolerability of CM336 will be evaluated in Phase 1 study, as well as the maximum tolerated dose (MTD) and the recommended dose level for Phase 2 study will be determined.

The efficacy of CM336 will be evaluated in Phase 2 study.


Eligibility criteria: Inclusion Criteria:

* Eastern Cooperative Oncology Group Performance Status (ECOG) of 0-2.
* Patients with relapsed or refractory MM who have failed or are intolerant to all therapies with known clinical benefit; patients must have received at least 2 prior anti-myeloma therapies which must contain at least one proteasome inhibitor (PI), one immunomodulatory drug (IMiD), and one anti-CD38 monoclonal antibody (if available).

Exclusion Criteria:

* Patients who had received BCMA-targeted therapy.
* Patients who had received CAR-T therapy.
* Patients who had received anti-tumor therapy within 3 weeks or 5 half-lives (whichever is shorter) prior to the first dose of CM336.

Primary outcomes:
measure: Dose-limiting toxicities (DLTs)
timeFrame: 21 days after the first dose
measure: Adverse events (AEs)
timeFrame: Up to 4.5 years
measure: Overall Response Rate (ORR)
timeFrame: up to 4.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Hongmei Jing
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Hematology & Blood Diseases Hospital, China
name: Lugui Lugui
role: PRINCIPAL_INVESTIGATOR
References: