louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03984630: Pregnancy Intervention Revolving Around Goal-focused Education (GIRAFE)
Official title: Feasibility of a Single Goal Intervention to Promote Appropriate Gestational Weight Gain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: Dietary Fiber
Gestational weight gain
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2019-06-13
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of study is to learn if consuming ≥30 grams or more of fiber per day can help pregnant women gain an appropriate amount of weight during their pregnancy.


Eligibility criteria: Inclusion Criteria:

* Women between 9 to 15 weeks pregnant
* BMI between 22.0 - 40.0 kg/m2 and between the
* Ages of 18-45 years
* Able to be recruited from the University of Kansas Medical Center (KUMC).

Exclusion Criteria:

* No Internet access
* Consuming more than 20 grams per day of fiber
* And/or with the following medical conditions during pregnancy:
* Pre-gestational diabetes
* Diagnosed with diabetes
* Pre-eclampsia
* Hypertension
* Other metabolic abnormalities
* Asthma
* Heart disease
* Smoking
* Drug abuse
* Pregnancies of multiples

Primary outcomes:
measure: Proportion of excessive gestational weight gain based on weight gain guidelines.
timeFrame: 12-24 weeks gestation and during pregnancy
Secondary outcomes:
measure: Total gestational weight gain
timeFrame: 12-24 weeks gestation and during pregnancy
measure: Total dietary fiber intake
timeFrame: 12-24 weeks gestation and during pregnancy
Other outcomes:
Locations:
Study officials:
affiliation: The University of Kansas Medical Center
name: Holly Hull, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hull HR, Herman A, Gibbs H, Gajewski B, Krase K, Carlson SE, Sullivan DK, Goetz J. The effect of high dietary fiber intake on gestational weight gain, fat accrual, and postpartum weight retention: a randomized clinical trial. BMC Pregnancy Childbirth. 2020 May 24;20(1):319. doi: 10.1186/s12884-020-03016-5.
Clinical trial NCT02289430: to Investigate the Pharmacokinetic Interactions and Safety Between Rosuvastatin and Ezetimibe in Healthy Male Volunteers
Official title: A Phase I Clinical Trial to Investigate the Pharmacokinetic Interactions and Safety Between Rosuvastatin and Ezetimibe in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: NVP Healthcare
Sponsor class: INDUSTRY
First posted: 2014-11-13
Enrollment: 59
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the drug interaction of pharmacokinetics of rosuvastatin and ezetimibe.

Detailed description: drug interaction : rosuvastatin, ezetimibe

Eligibility criteria: Inclusion Criteria:

* Healthy male subjects age between 19 and 45 singed informed consent

Exclusion Criteria:

* Hypotension or hypertension has a history of allergy reaction of this drug or other drugs

Primary outcomes:
measure: Area Under Curve
timeFrame: 0-24h
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Gachon University Gil Medical Center
name: Shin D Seong, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01612130: Valerian for Conscious Sedation in Patients Submitted to Impacted Lower Third Molars Surgery
Official title: Valeriana Officinalis L. for Conscious Sedation in Patients Submitted to Impacted Lower Third Molars Surgery: A Randomized, Double-Blind, Placebo-Controlled Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Anxiety
Blood Pressure
Heart Rate
Lead sponsor: Federal University of the Valleys of Jequitinhonha and Mucuri
Sponsor class: OTHER
Collaborators: name: University of Campinas, Brazil
First posted: 2012-06-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The aim of the present study was to evaluate the efficacy of Valeriana officinalis L. 100 mg in single oral doses one hour preoperative as conscious sedation during the impacted lower third molar surgery.

Detailed description: Evaluate the efficacy of Valeriana officinalis L. (Valerian) for control of anxiety during third molar surgery. Study design: A single oral dose of either valerian (100 mg) or placebo was randomly administered one hour before each surgical procedure to 20 volunteers between 17 and 31 years of age. Anxiety level was assessed through questionnaires, physiological parameters (blood pressure and heart rate) and the observation of signs.

Eligibility criteria: Inclusion Criteria:

* Indication for bilateral extraction of asymptomatic impacted mandibular third molars in similar positions based on the Pell \& Gregory classification

Exclusion Criteria:

* Use of any type of medication in the 15 days prior to the onset of the study; history of hypersensitivity to the drugs, substances or materials employed in the experiment; pregnancy or lactation

Primary outcomes:
measure: Signs and symptoms of anxiety
timeFrame: 1 day (during dental appointment)
measure: assessment of the blood pressure
timeFrame: 1 day (during dental appointment)
measure: Assesment of heart rate
timeFrame: 1 day (during dental appointment)
Secondary outcomes:
measure: Oxygen saturation
timeFrame: 1 day (During dental appointment)
measure: Side effects of drugs
timeFrame: 1 week
Other outcomes:
Locations:
city: Piracicaba
country: Brazil
facility: Oral-Maxillofacial Surgery Sector of the Piracicaba Dental School, Universidade Estadual de Campinas (Brazil)
state: São Paulo
Study officials:
affiliation: Federal University of the Valleys of Jequitinhonha and Mucuri
name: Marcos Pinheiro, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00244530: Prophylactic Effect of Nifedipine on Further Decline in Renal Function in Patients Undergoing Open-Heart Surgery
Official title: Postoperative Renal Function After Open-Heart Surgery in Patients With Impaired Renal Function Preoperatively. A Study of the Calcium Channel Blocker Nifedipine's Prophylactic Effect on Further Decline in Renal Function.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Failure, Chronic
Coronary Artery Disease
Keywords: Preventive Therapy
Calcium Channel Blockers
Kidney Failure, Chronic
Coronary Artery Bypass
Heart Valve Prosthesis Implantation
Lead sponsor: University of Oslo School of Pharmacy
Sponsor class: OTHER
First posted: 2005-10-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To compare renal function (51Cr-EDTA clearance) 48 hours post open-heart surgery (coronary bypass or valve surgery) in patients with impaired renal function after randomization to either nifedipine infusion at start of surgery and the following 24 hours or placebo (0.9% saline infusion). Study hypothesis is that nifedipine has a prophylactic effect on decline in renal function.


Eligibility criteria: Inclusion Criteria:

1. Patients of either gender above 18 years of age.
2. Patients with significant coronary stenosi(e)s (≥ 75% coronary artery lumen surface stenosi(e)s and / or aortic- or mitral valve vitriuim that are accepted for coronary artery bypass surgery and/or valve replacement surgery.
3. Patients with impaired renal function, defined as increased serum- creatinine. Men: ≥ 150 µmol/l and Women: ≥130 µmol/l.

Exclusion Criteria:

1. Patients on maintenance hemodialysis
2. Renal transplant patients
3. Patients with ejection fraction ≤ 35%
4. Patients with unstable angina pectoris

Primary outcomes:
measure: Primary efficacy endpoint is change in renal function, evaluated by 51Cr-EDTA clearance between 24 hours pre open-heart surgery and 48 hours post open-heart surgery. Sample size is 20, ten in each group.
Secondary outcomes:
measure: Change in renal function after open-heart surgery, as measured by cimetidine refined serum creatinine clearance with measurements preoperatively and 2-6 hours, 20-24 hours and 44-48 hours postoperatively. Need for dialysis post-operatively.
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Rikshospitalet University Hospital
Study officials:
affiliation: Rikshospitalet University Hospital, Oslo, Norway
name: Jan F Bugge, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00752830: To Evaluate the Effect of Food on the Pharmacokinetics (PK) of AZD0328
Official title: A Phase I, Open, Randomized, Single-Dose, Two-Treatment (Fed Versus Fasting), Two-Period Cross-Over Single-Centre Study to Evaluate the Effect of Food on the Pharmacokinetics of AZD0328 Following Oral Administration (Capsule) in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: AZD0328
Food Effect
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-09-15
Enrollment: 14
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of the study is to evaluate the effect of food on the pharmacokinetics of AZD0328 in healthy male volunteers. AZD0328 will be administered as a single oral dose (capsule) during two treatment periods, after food intake or during fasting condition.


Eligibility criteria: Inclusion Criteria:

* Healthy male Caucasian subjects.
* Clinically normal physical findings, laboratory values, vital signs and resting ECG as judged by the investigator.
* Signed informed consent form

Exclusion Criteria:

* History of clinically significant cardio or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder (including dyspepsia or GERD) or any other major disorder that may interfere with the study.
* Intake of another investigational drug or participation in another study which may interfere with the objectives of the study, within 12 weeks before the administration of the investigational product.

Primary outcomes:
measure: PK variables
timeFrame: Several PK samples during the study days
Secondary outcomes:
measure: Safety variables (adverse events, blood pressure, laboratory measurements and paper ECGs)
timeFrame: During the whole treatment period
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D Södertälje, Sweden
name: Didier Meulien, MD
role: STUDY_DIRECTOR
affiliation: AstraZeneca Clinical Pharmacology Unit, AstraZeneca R&D Lund,Sweden
name: Gabriella Samuelsson Palmgren, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03897530: Experimental Tobacco Marketplace in Regulating Flavored Tobacco Products in Menthol Cigarette Smokers
Official title: Flavored Tobacco Product Regulation: Behavioral Economic Demand, Visual Attention, and Flavored Tobacco Product Availability
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cigarette Smoking
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-04-01
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This trial uses an Experimental Tobacco Marketplace to study the purchase of tobacco products in menthol cigarette smokers. Determining the level of substitutability of both flavored and unflavored/tobacco flavored e-cigarettes when menthol cigarettes are available and unavailable can help determine if a flavor ban (of either menthol cigarettes and/or flavored e-cigarettes) will lead to smoking cessation and/or harm reduction. A greater understanding of tobacco product purchasing could help inform possible regulatory actions by the Food and Drug Administration.

Detailed description: Participants view and purchase hypothetical tobacco products during four distinctly different Experimental Tobacco Marketplace (ETM) conditions. During the session, participants are presented with these randomly ordered conditions: menthol cigarettes and five flavored e-cigarettes (menthol/mint, fruits, sweets, alcohol, snacks/meals), menthol cigarettes and both unflavored and tobacco-flavored e-cigarettes, non-menthol cigarettes and five flavored e-cigarettes, and non-menthol cigarettes and both unflavored and tobacco-flavored e-cigarettes. Participants' visual attention is evaluated by eye-tracking equipment.

Eligibility criteria: Inclusion Criteria:

* Menthol cigarette smokers who report smoking a brand that has a non-menthol equivalent.
* Residing in Western New York.
* Voluntarily provide informed consent to participate in the study.

Exclusion Criteria:

* Any known history of macular degeneration, glaucoma, cataracts, eye implant, permanently dilated pupils or the use of a screen reader/magnifier.
* The following special populations will not be included:

  * Adults unable to consent
  * Individuals who are not yet adults (infants, children, teenagers)
  * Prisoners
  * Pregnant women

Primary outcomes:
measure: Cessation of Menthol flavored cigarettes
timeFrame: At the time of the session , assessed up to 15 months
measure: Eye tracking metrics
timeFrame: At the time of the session , assessed up to 15 months
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Amanda Quisenberry
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04689230: Small Incision Technique Versus Upper Blepharoplasty in Upper Eyelid Medial Pad Fat Removal
Official title: Comparison of the Efficacy Between Small Incision Technique and Upper Blepharoplasty in Treatment of Upper Eyelid Medial Pad Fat Bulge
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Eyelid Diseases
Keywords: upper eyelid pad fat
blepharoplasty
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2020-12-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Medial upper eyelid pad of fat bulge is a common problem. Small incision surgery could be a time-efficient, minimally invasive and scar formation procedure .

Detailed description: Traditional upper eyelid blepharoplasty: an entire length upper eyelid crease followed by proper dissection are applied . identification and removal of medial pad of fat.

Small Incision technique: 4 mm medial upper eyelid small incision followed by proper dissection to gain direct access to the medial fat pad removal

Eligibility criteria: Inclusion Criteria:

* upper eyelid medial pad of fat bulge

Exclusion Criteria:

Other eyelid diseases and previous eyelid surgery

Primary outcomes:
measure: global aesthetic improvement scale
timeFrame: 3 months
Secondary outcomes:
measure: duration of surgery
timeFrame: 3 months
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: INMC
Study officials:
affiliation: Benha university faculty of medicine
name: Tarek Elahamky, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01292330: A Clinical Study to Evaluate the Clinical Outcomes of Hepatectomy With Nutritional Risk After Preoperative Nutritional Support
Official title: A Clinical Study to Evaluate the Clinical Outcomes of Hepatectomy With Nutritional Risk After Preoperative Nutritional Support
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Cancer
Keywords: liver Tumor
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2011-02-09
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: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Objective:to Study the clinical outcomes of hepatectomy with Nutritional risk After Preoperative Nutritional Support.

Study design:

1.Prospective，randomized, controlled clinical study;2.Patients: The subjects were from Peking Union Medical College Hospital (PUMCH).

Study arrangement:

1. The collection of patients with selected standard
2. Preoperative evaluation included nutritional status,liver function and tumor characteristics
3. The experimental group received Preoperative Nutritional Support for 4 days,the control group got nothing
4. Both groups received conventional therapy after operation
5. The comparation of the clinical outcomes in both groups


Eligibility criteria: Inclusion Criteria:

1. A diagnosis of hepatocellular carcinoma (HCC) was made before operation
2. Nutritional Risk Screening 2002(NRS-2002) was Greater or equal 3 points with in 24 hours after admission

Primary outcomes:
measure: postoperative complications
timeFrame: 2 years
Secondary outcomes:
measure: hospitalization expenses and length of stay
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Yilei Mao
state: Beijing
Study officials:
References:
citation: Lu X, Li Y, Yang H, Sang X, Zhao H, Xu H, Du S, Xu Y, Chi T, Zhong S, Yu K, Mao Y. Improvement of nutritional support strategies after surgery for benign liver tumor through nutritional risk screening: a prospective, randomized, controlled, single-blind clinical study. Hepatobiliary Surg Nutr. 2013 Feb;2(1):14-21. doi: 10.3978/j.issn.2304-3881.2012.11.04.
Clinical trial NCT06489730: HAPH Registry: Time Course and Prognostic Significance of Pulmonary Artery Pressure in Highlanders.
Official title: HAPH Registry: Time Course and Prognostic Significance of Pulmonary Artery Pressure in Highlanders.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: High Altitude Pulmonary Hypertension
Sleep Apnea
Keywords: high altitude illness
pulmonary hypertension
sleep apnea
disease progression
hypoxia
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
First posted: 2024-07-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Highlanders living at Aksay plateau will be invited to participate.

Brief summary: The purpose of the current study is to evaluate the clinical and physiologic course of Kyrgyz highlanders with high altitude pulmonary hypertension (HAPH) by performing a longitudinal cohort study. To this end, the investigators will invite the same highlanders who participate din the study in 2017 to undergo follow-up examinations in 2024, in order to allow comparisons of current results with baseline data from 2017.


Eligibility criteria: Inclusion Criteria:

* Permanently living \>2500 m
* Written informed consent

Exclusion Criteria:

* Highlanders who cannot follow the study investigations,
* Patients with moderate to severe concomitant lung disease (FEV1\<70% or forced vital capacity \<70%), severe parenchymal lung disease, heavy smoking \>20 cigarettes/day or \>20 pack-years.
* Coexistent unstable systemic hypertension or coronary artery disease that required adjustment of medication within the last 2 months
* Regular use of medication that affects control of breathing (benzodiazepines, opioids, acetazolamide)

Primary outcomes:
measure: Change in pulmonary artery pressure in highlanders
timeFrame: Year 2017 to 2024
Secondary outcomes:
measure: Change in pulmonary artery pressure between highlanders and lowlanders
timeFrame: Year 2017 to 2024
measure: Change in TRP/CO in highlanders
timeFrame: Year 2017 to 2024
measure: Progression of oxygen desaturation index
timeFrame: Year 2017 to 2024
measure: Progression of quality of life
timeFrame: Year 2017 to 2024
measure: Progression of arterial blood gases
timeFrame: Year 2017 to 2024
measure: Progression of right heart strain
timeFrame: Year 2017 to 2024
Other outcomes:
Locations:
Study officials:
affiliation: National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
name: Talant M Sooronbaev, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Zurich, Department of Pulmonology
name: Silvia Ulrich, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04329130: Chidamide Combination With Lenalidomide in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma
Official title: Chidamide Combination With Lenalidomide in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma: an Open Label, Single Arm, Phase II Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Relapsed or Refractory Peripheral T-cell Lymphoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-04-01
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this open label,single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of Chidamide combination with lenalidomide for relapsed or refractory peripheral T-cell lymphoma.

Detailed description: Histone deacetylase(HDAC) inhibitor has been used in relapsed or refractory peripheral T-cell lymphoma.There are no international studies of Chidamide combination with lenalidomide for relapsed or refractory peripheral T-cell lymphoma. Therefore, this study intends to select the oral HDAC inhibitor Chidamide combined with lenalidomide for relapsed or refractory peripheral T-cell lymphoma, and explore its efficacy and safety.

Eligibility criteria: Inclusion Criteria:

* peripheral T cell lymphoma (PTCL);
* no remission or relapse after at least one previous systemic treatment；
* at least one assessable lesion；
* 18-75 years;
* ECOG PS 0-2;
* proper functioning of the major organs;
* expected survival time ≥3 months.

Exclusion Criteria:

* previous received treatment of HDAC inhibitor or lenalidomide;
* central nervous system (CNS) involvement;
* serious heart problems;
* known allergies to experimental drug ingredients;
* diagnosed with or receiving treatment for a malignancy other than lymphoma;
* uncontrolled active infection, with the exception of tumor-related b-symptom fever;
* unable or unwilling to receive antithrombotic therapy;
* history of deep vein thrombosis (DVT) or pulmonary embolism (PE) in the past 12 months;

Primary outcomes:
measure: ORR
timeFrame: 4-years
Secondary outcomes:
measure: PFS
timeFrame: 4-years
measure: DOR
timeFrame: 4-years
measure: OS
timeFrame: 4-years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Qingqing Cai, MD
role: PRINCIPAL_INVESTIGATOR
References: