louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00736411: In Vitro Fertilization (IVF) and Acupuncture for Infertility
Official title: IVF and Acupuncture for Infertility: A Randomized Controlled Trail
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infertility
Keywords: infertility
IVF
acupuncture
Lead sponsor: Pacific Fertility Center
Sponsor class: OTHER
First posted: 2008-08-15
Enrollment: 320
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this investigation is to determine the value of combining acupuncture with infertility patients undergoing In Vitro Fertilization (IVF). The investigators will measure the outcomes of endometrial lining, uterine blood flow, hormones, stress levels, and pregnancy and live birth rates.


Eligibility criteria: Inclusion Criteria:

* females between 21 and 42 years old
* primary or secondary infertility
* no more than 2 previously failed IVF cycles
* undergoing IVF
* FSH \< 11

Exclusion Criteria:

* FSH \> 11
* using an egg donor
* using PGD
* using heparin or lovanox protocols
* estradiol level less than 20 or over 80
* taking herbal therapy

Primary outcomes:
measure: pregnancy
timeFrame: week 10 of study
Secondary outcomes:
measure: uterine blood flow
timeFrame: final measurement in week 8
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Pacific Fertility Center
state: California
Study officials:
affiliation: Pacific Fertility Center
name: Caylie J See, L.Ac.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04059211: Sensitivity and Specificity of Urinary Dipstick in Emergency Departments
Official title: Sensitivity and Specificity of Urinary Dipstick in Emergency Departments
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Proteinuria
Keywords: urinary dipstick
emergency department
Lead sponsor: Sonderborg Hospital
Sponsor class: OTHER_GOV
First posted: 2019-08-16
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients above 18 years of age who were admitted to the emergency department in Sonderborg and who gave their consent.

Brief summary: Urinary dipsticks are commonly used in emergency departments since they are a cheap and quick diagnostic tool. However the sensitivity and specificity of urinary dipsticks might be compromised in emergency departments due to fluid imbalance and acute illness itself.

Detailed description: The study is designed as a prospective observational study on the emergency department in Sonderborg, Southern Denmark.

All patients above 18 years of age who have given their consent are included. Urinary dipstick and albumin creatinine ratio is obtained simultaneously within 48 hours after admission on the emergency department.

Patient with a positive urinary dipstick will be asked to deliver another urinary dipstick and albumin creatinine ratio 3-8 weeks later.

To our knowledge has the specificity and sensitivity of urinary dipstick for protein not been described, yet. Our design will give us the possibility not only to quantify specificity and sensitivity in the acute phase on the emergency department but in the non-acute phase after discharge from the emergency department, as well.

Eligibility criteria: Inclusion Criteria:

* All patients above 18 years of age who were admitted to the emergency department in Sonderborg and who gave their consent

Exclusion Criteria:

* anuria

Primary outcomes:
measure: Sensitivity and specificity of urinary dipstick for proteinuria on emergency departments
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sønderborg
country: Denmark
facility: Sonderborg Hospital
state: Southern Denmark
Study officials:
References:
Clinical trial NCT00973011: A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of FCFD4514S in Patients With Geographic Atrophy
Official title: A Phase Ia, Multicenter, Open-Label, Single-Dose, Dose-Escalation Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of FCFD4514S in Patients With Geographic Atrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Geographic Atrophy
Keywords: GA
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2009-09-09
Enrollment: 18
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Phase Ia, open-label, multicenter study will consist of a single-dose, dose-escalation study of the safety, tolerability, pharmacokinetics, and immunogenicity of an intravitreal (ITV) injection of FCFD4514S in patients with Geographic Atrophy (GA).


Eligibility criteria: Inclusion Criteria:

* Ability and willingness to undertake all scheduled visits and assessments
* Agreement to use an effective form of contraception for the duration of the study
* Geographic atrophy (GA) at least 0.75 disc areas in the absence of choroidal neovascularization (CNV)

Exclusion Criteria:

* Treatment for active systemic infection
* Predisposition or history of increased risk for infection
* Active malignancy
* History of medical conditions, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or that renders the patient at high risk for treatment complications
* GA in either eye due to non-AMD causes
* Active or history of ocular and intraocular conditions in the study eye (except GA)
* History of vitreoretinal surgery or laser photocoagulation in the study eye
* Prior treatment for AMD (except vitamins and minerals)
* History of intravitreal (ITV) drug delivery
* Intraocular surgery (including cataract surgery) in the study eye within 3 months preceding Day 0
* Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals)

Primary outcomes:
measure: Safety and tolerability of the study drug
timeFrame: Through study completion or early study discontinuation
Secondary outcomes:
measure: PK parameters of study drug (total exposure, maximum observed serum concentration, and time of maximum observed serum concentration)
timeFrame: Through study completion or early study discontinuation
Other outcomes:
Locations:
Study officials:
affiliation: Genentech, Inc.
name: Erich Strauss, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04514211: Heart Rate Variability and Postoperative Nausea Vomiting
Official title: The Effects of Propofol and Sevoflurane on Postoperative Heart Rate Variability and Postoperative Nausea Vomiting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Nausea and Vomiting
Keywords: postoperative nausea and vomiting
heart rate variability
propofol
sevoflurane
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2020-08-14
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 20\~50 years old female patients who scheduled breast surgery under general anesthesia

Brief summary: Propofol and sevoflurane have different effects on heart rate variability. It has not yet been reported whether this difference in effect remains at recovery time after anesthesia and the difference is related to postoperative nausea and vomiting has not been studied. The aim of this study is observe whether propofol and sevoflurane have different effects on heart rate variability during recovery and the differences can predict the occurrence of postoperative nausea and vomiting.

Detailed description: Different types of anesthetics have different effects on heart rate variability. However It has not yet been reported whether this difference in effect remains at recovery time after anesthesia.

Several studies have been reported that preoperative heart rate variability predicted the occurence of postoperative nausea and vomiting. However, whether the difference in heart rate variability after anesthesia is related to the difference in postoperative nausea and vomiting has not been studied. Therefore, this study aims to observe whether propofol and sevoflurane have differences during recovery period after anesthesia in heart rate variabiliy. In addition, we want to examine that these differences during recovery period in heart rate variability can predict the occurrence of nausea and vomiting within 24 hours after surgery.

Eligibility criteria: Inclusion Criteria:

* Scheduled breast surgery under general anesthesia

Exclusion Criteria:

* Arrhythmia
* Uncooperative with the measuring heart rate variability
* Diabetes
* Hypertension on medication
* Patients taking psychiatric drugs
* Thyroid disease

Primary outcomes:
measure: heart rate variability in recovery room
timeFrame: within 1 hour
Secondary outcomes:
measure: Postoperative nausea vomiting impact scale
timeFrame: 48 hours after anesthesia
measure: The incidence of postoperative nausea and vomiting
timeFrame: 48 hours after anesthesia
measure: Patient's satisfaction about postoperative nausea and vomiting
timeFrame: 48 hours after anesthesia
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou university school of medicine
state: Gyeonggi-do
Study officials:
affiliation: Ajou University School of Medicine
name: In Kyong Yi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04238611: Minimally-Invasive Realtime Assessment of Continuous Lactate in Exercise
Official title: Minimally-Invasive Realtime Assessment of Continuous Lactate in Exercise
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Exercise
Lactate
Keywords: Minimally-invasive
Microneedle
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2020-01-23
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Lactate is a compound produced as a by-product of glycolysis. The increase in lactate concentration can result from a variety of causes, such as during anaerobic metabolism in exercise or haemodynamic shock in conditions such as sepsis.

The study will aim to validate a novel microneedle-based minimally invasive device for the continuous measurement of lactate during exercise.

Detailed description: Lactate is a compound produced as a by-product of glycolysis. The increase in lactate concentration can result from a variety of causes, such as during anaerobic metabolism in exercise. The measurement of blood lactate during exercise has been routinely used to determine individual anaerobic thresholds, and optimise training in athletes.

The measurement of the lactate trend requires multiple blood tests, and this can be uncomfortable. The need for repeated procedures may therefore restrict the full utility of the biomarker. Although point-of-care lactate measurements are possible, the barriers to initiating testing may also limit its role in clinical decision-making.

The aim of the study is the validation of the microneedle-based lactate biosensor for real-time continuous lactate measurement in healthy volunteers during exercise as proof-of-concept.

Eligibility criteria: Inclusion Criteria:

1. Consenting adults ≥ 18 years old
2. Healthy with no other previous medical history
3. Able to perform moderately intensive exercise without difficulty for at least 30 minutes continuously, and engages in regular aerobic exercise at least twice a week

Exclusion Criteria:

1. Active inflammatory skin condition such as eczema or dermatitis
2. Active soft tissue infection or infection at any site
3. Known hypersensitivity to any microneedle component or dressings
4. Presence of any implantable electronic devices such as a pacemaker or stimulators

Primary outcomes:
measure: Performance of microneedle
timeFrame: 30 minutes
Secondary outcomes:
measure: Acceptability
timeFrame: 2 hours
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College London
Study officials:
affiliation: Imperial College London
name: Alison H Holmes
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05591911: Urine Gene Analysis for Pathogen Detection
Official title: Urine Gene Analysis for Pathogen Detection, and Resistance Gene Identification for the Urinary Tract Infection Diagnosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Tract Infections
Keywords: Urinary tract infection
Urine culture
Bacteriel growth
Antibiotics
PCR
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Vikor Scientific
name: Thermo Fisher Scientific, Inc
First posted: 2022-10-24
Enrollment: 96
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female and male patients over 60 years old who admit with acute urinary tract infection symptoms to the ambulatory clinics will be included in this research.

Brief summary: The objective of this study is the detection, quantification, and resistance gene identification of pathogens by using the urine of patients with urinary tract infection (UTI) symptoms.


Eligibility criteria: Inclusion Criteria:

* Adult men and women 60 years and older who have urinary tract infection
* Can participate in the informed consent process
* Presenting to the clinic with symptoms of UTI or cystitis with no recent history of UTI within the past 21 days
* Able to provide sufficient urine sample volume via clean catch or catheterization for urinalysis, conventional urine culture, and PCR
* Understand and are willing to comply with the study requirements.
* Sample collection able to be sent out the same day via courier

Exclusion Criteria:

* Individuals under 60 years of age
* Unable to provide informed consent
* Urinary diversion of any type
* Chronic indwelling urinary catheter
* No recent history of UTI within the past 21 days
* No antibiotic therapy within the past 21 days
* No recent therapy with Phenazopyridine

Primary outcomes:
measure: Time in hours from patient presentation to optimal antibiotic prescription
timeFrame: Up to 30 days
Secondary outcomes:
measure: Antibiotic costs as measured by prescription records
timeFrame: Up to 30 days
measure: Number of patients with antibiotic change as measured by prescription records
timeFrame: Up to 30 days
measure: Duration of antibiotic usage as measured by prescription records
timeFrame: Up to 30 days
measure: Number of any HCP visits for same issue as measured by patients reports/medical records
timeFrame: Up to 30 days
measure: Number of hospitalization related to UTI as measured by patients reports/medical records
timeFrame: Up to 30 days
measure: Number of additional diagnostic procedures completed in relation to UTI as measured by patients reports/medical records
timeFrame: Up to 30 days
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: David Sheyn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01277211: A Study to Evaluate the Effectiveness of NuvaRing® to Prevent Pregnancies in Chinese Women (P06450)
Official title: A Randomized, Open-Label, Controlled, Multi-Center Trial to Evaluate the Contraceptive Efficacy, Cycle Control, Safety and Acceptability of NuvaRing® (SCH 900702) in Chinese Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraception
Keywords: Contraception
NuvaRing
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2011-01-14
Enrollment: 983
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a study to assess the effectiveness of NuvaRing® (SCH 900702) for the prevention of pregnancy in fertile Chinese women. The acceptability and safety of NuvaRing® will also be assessed and compared with that of Yasmin.

Detailed description: The purpose of this study is to assess the contraceptive efficacy of NuvaRing in fertile Chinese women; to assess vaginal bleeding pattern (cycle control), general safety, and acceptability of NuvaRing; and to evaluate the NuvaRing's effect on dysmenorrhea.

Eligibility criteria: Key Inclusion Criteria:

* Sexually active Chinese women, at risk for pregnancy and not planning to use condoms during trial medication use
* Women in need for contraception and willing to use a hormonal contraceptive method for 13 cycles
* Body mass index ≥18 and ≤29 kg/m\^2

Key Exclusion Criteria:

* Contraindications for contraceptive steroids
* Abnormal cervical smear corresponding to indeterminate changes at screening
* Clinically relevant abnormal laboratory result at screening as judged by the investigator.

Primary outcomes:
measure: Pearl Index, by Treatment Group
timeFrame: Up to 1 year
Secondary outcomes:
measure: Percentage of Participants With Intermenstrual (Breakthrough) Bleeding/Spotting, by Cycle
timeFrame: Up to 1 year
measure: Percentage of Participants With Absence of Withdrawal Bleeding, by Cycle
timeFrame: Up to 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Fan GS, Ren M, Di W, Su P, Chang Q, Wu S, Qin Y, Korver T, Marintcheva-Petrova M, Yacik C, McCrary Sisk C, Wang G. Efficacy and safety of the contraceptive vaginal ring (NuvaRing) compared with a combined oral contraceptive in Chinese women: a 1-year randomised trial. Eur J Contracept Reprod Health Care. 2016 Aug;21(4):303-9. doi: 10.1080/13625187.2016.1186269. Epub 2016 Jun 24.
Clinical trial NCT00970411: Study of KRN951 in Patients With Solid Tumors
Official title: An Open-label, Non-randomised Dose Escalation Study of KRN951 Administered Orally to Patients With Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumors
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2009-09-02
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and tolerability of KRN951 administered to patients with solid tumors. In the single dose period, patients in each cohort will receive one oral dose of KRN951 in the first day, followed by a 6-day rest period during which no treatment is received. After that, patients in each cohort will receive one oral dose of KRN951 daily over a 21-day treatment period, followed by a 7-day rest period during which no treatment is received. Treatment will be continued in the absence of disease progression or unacceptable adverse events.


Eligibility criteria: Inclusion Criteria:

* Signed written informed consent
* Solid tumors to be unresponsive to, or untreatable by standard therapies
* ≥ three-month life expectancy
* Eastern Cooperative Oncology Group Performance Status score of 0, 1 or 2

Exclusion Criteria:

* Hematologic abnormality
* Myocardial infarction or clinically symptomatic left ventricular failure
* Active hypertension or controllable hypertension more than 3 antihypertensive medications
* Symptomatic CNS metastasis
* Unhealed wounds
* Active infections
* Hepatic or renal functional disorder
* Any of the HBs antigen, HCV antibody and HIV antibody positivity
* Prior use of any chemotherapy, radiotherapy, immunotherapy or surgery within four weeks previous to first dose of study drug
* Pregnant or lactating women
* Women of childbearing potential and fertile men, unless willing to use adequate contraceptive protection

Primary outcomes:
measure: To define the maximum tolerated dose (MTD) of KRN-951 when administered orally for 21 days followed by a 7-day rest period.
measure: To evaluate the safety profile and the tolerability of KRN951 throughout the study period by assessing adverse events and laboratory values recorded during treatment.
Secondary outcomes:
measure: To determine the pharmacokinetics of KRN951 in serum
measure: To describe biological and clinical anti-tumor activity
Other outcomes:
Locations:
city: Shizuoka
country: Japan
Study officials:
References:
Clinical trial NCT03363711: AYA STEPS RCT: AYA Self-Management Via Texting, Education & Plans for Survivors
Official title: AYA STEPS RCT: AYA Self-Management Via Texting, Education & Plans for Survivors
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Adolescent and Young Adult (AYA) Cancer Survivors
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2017-12-06
Enrollment: 25
Sex: ALL
Minimum age (years): 15
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 15-29 year olds with a history of malignant cancer diagnosis.

Brief summary: The proposed project will leverage two programs of research at UPenn and CHOP that are delivering technology-based interventions to adolescent and young adult (AYA) cancer survivors.

In the proposed study, all AYA survivors will receive a care plan via a tool (Smart-ALACC). They will then be randomized to receive (or not) a mobile health application (AYA STEPS) that will provide tailored messages to enhance uptake of their care plan.


Eligibility criteria: Inclusion Criteria:

* AYA is 15-29 year old with a history of a malignant cancer diagnosis;
* Completed cancer treatment and are currently in remission or receiving cancer survivorship care;
* Seen for follow-up oncology care at CHOP or Penn;
* For AYA less than 18 years old, must have a caregiver to provide informed consent.

Exclusion Criteria:

* Cognitive impairments that would limit AYA ability to independently care for health as determined by the medical team.
* Absence of the inclusion criteria

Primary outcomes:
measure: Number of Completed mobile data and questionnaires
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Christine Hill-Kayser, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Psihogios AM, King-Dowling S, O'Hagan B, Darabos K, Maurer L, Young J, Fleisher L, Barakat LP, Szalda D, Hill-Kayser CE, Schwartz LA. Contextual Predictors of Engagement in a Tailored mHealth Intervention for Adolescent and Young Adult Cancer Survivors. Ann Behav Med. 2021 Nov 18;55(12):1220-1230. doi: 10.1093/abm/kaab008.