louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03525990: Study Evaluating the Impact of Electronic Surveys on Patient-physician Communication and Quality of Life in Breast Cancer Patients
Official title: PRO-COM Project: Randomized-controlled Study Evaluating the Impact of Electronic Patient Reported Outcome (ePRO) Surveys on Patient-physician Communication and Quality of Life in Patients With Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasm Malignant Female
Lead sponsor: Klinikum Wels-Grieskirchen
Sponsor class: OTHER
First posted: 2018-05-16
Enrollment: 62
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: PRO-COM Project: Randomized-controlled study evaluating the impact of electronic patient reported outcome (ePRO) surveys on patient-physician communication and quality of life in patients with advanced breast cancer


Eligibility criteria: Inclusion Criteria:

* Stage IV breast cancer
* Start of a systemic anti cancer therapy: chemotherapy -/+ antibody therapy 1st until 3rd line (palliative), endocrine therapy or other therapy without limit
* Estimated life expectancy of minimum six months
* Signed informed consent
* No cognitive or speech impairments

Primary outcomes:
measure: Patient-physician communication
timeFrame: Up to six months
Secondary outcomes:
measure: Quality of life assessment
timeFrame: Arm A: at every visit for six months; Arm B: at baseline, three months, six months
measure: Frequency of discontinuations of therapy
timeFrame: Up to six months
measure: Duration of communication between physician and patient
timeFrame: At baseline, three months, six months in both groups
Other outcomes:
Locations:
city: Braunau Am Inn
country: Austria
facility: A.ö. Krankenhaus St. Josef Braunau GmbH
state: Upper Austria
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen GmbH
state: Upper Austria
Study officials:
affiliation: Klinikum Wels-Grieskirchen GmbH, 4. Interne
name: Vera Trommet, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05891990: Immediate Implant Placement With Sticky Tooth Versus Autogenous Tooth Graft In Cases With Labial Plate Dehiscence
Official title: Evaluation of Soft and Hard Tissue Changes After Immediate Implant Placement With Sticky Tooth Versus Autogenous Tooth Graft In Cases With Labial Plate Dehiscence: A 1-Year Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Immediate Implant
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of Soft and Hard Tissue Changes After Immediate Implant Placement With Sticky Tooth Versus Autogenous Tooth Graft for management of Cases With Labial Plate Dehiscence

Detailed description: In patients with labial plate dehiscence in the esthetic zone, there is no difference between the use of tooth-derived granules in combination with platelet-rich fibrin ("sticky tooth") and autogenous tooth graft in conjunction with immediate implant placement in enhancing the amount of bone labial to the implant

Eligibility criteria: Inclusion Criteria:

* Non-restorable teeth in the esthetic zone with a defect of labial bone.

  * Teeth with no acute inflammation.
  * Patients are free from any systemic condition that may affect the healing.
  * Availability of bone apical and palatal to the socket to provide primary stability
  * Good oral health.
  * Willingness to sign the informed consent form.

Exclusion Criteria:

* Heavy smoker (\> 10 cigarettes/day)
* Pregnant females
* Contraindication for Implant surgery.
* Patients with poor oral hygiene.
* Acute inflammation in the site of implantation and adjacent tissue.
* A history of radiotherapy in the head or neck region.
* Patients with systemic diseases like uncontrolled diabetes mellitus, coagulation disorders, alcohol or drug abuse not suitable for implantation

Primary outcomes:
measure: Radiographic width of bone labial to the implant
timeFrame: 1 year
Secondary outcomes:
measure: Radiographic horizontal bucco-palatal bone changes
timeFrame: 1 year
measure: Radiographic vertical bone changes
timeFrame: 1 year
measure: Esthetic evaluation (The pink esthetic score)
timeFrame: 1 year
measure: Implant stability
timeFrame: 6 months
measure: Gingival Thickness
timeFrame: 1 year
measure: Width of the Keratinized Tissue
timeFrame: 1 year
measure: Midfacial recession
timeFrame: 1 year
measure: Post-Operative Pain
timeFrame: 7 days
measure: Post-Operative patient's Satisfaction
timeFrame: 1 year
measure: Post-operative swelling
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04390490: Clinical Trails of Photoelectrochemical Immunosensor for Early Diagnosis of Acute Myocardial Infarction
Official title: Clinical Trails of Photoelectrochemical Immunosensor for Early Diagnosis of Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Myocardial Infarction
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2020-05-15
Enrollment: 100
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: DIAGNOSTIC

Brief summary: The aim of this prospective randomized controlled clinical trial will evaluate the sensitivity, precision and effectiveness of photoelectrochemical immunosensor for early diagosis of acute myocardial infarction.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Symptoms of chest pain

Exclusion Criteria:

* Patients who will undergo immediate PCI Pregnant
* Lactating women
* Patients with mental disorders
* Patients are using other experimental drugs; Refusal to provide informed.

Primary outcomes:
measure: Effectiveness of photoelectrochemical immunosensor
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ethics Committee of Xinhua Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT00409890: The Effect of Hyoscine Butyl Bromide on the First Stage of Labor in Term Pregnancies
Official title: The Effect of Hyoscine Butyl Bromide on the First Stage of Labor in Term Pregnancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Labor Stage, First
Keywords: Buscopan
Hyoscine
Shortens
Labor
Stage
Lead sponsor: University Hospital of the West Indies
Sponsor class: OTHER
First posted: 2006-12-12
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine whether hyoscine butyl bromide is effective in shortening the first stage of labor, with no increase in maternal or neonatal complications.

Detailed description: Hyoscine butyl bromide has been used to shorten the duration of labor in several hospitals here in Jamaica, as it has elsewhere in the world. Thus, it represents a new addition to the armamentarium of active management. The mechanism by which it acts in the context of labor has not yet been elucidated, and the evidence for its efficacy was previously largely anecdotal. The specific objectives of this project are to assess whether hyoscine butyl bromide (in the form of Buscopan®) is effective in hastening cervical effacement and dilatation, thus shortening the duration of the first stage of labor. We also intend to determine whether the use of hyoscine butyl bromide in the first stage of labor has any associated increase in complications, such as an increase in blood loss or rate of Caesarean deliveries, or a decrease in neonatal APGAR scores.

The study was designed as a double blind, randomized, controlled, clinical trial comparing two groups of patients matched for age and parity. One group of patients received the 20 mg(1 ml)of hyoscine butyl bromide, while the other (control) group received 1 ml of normal saline (placebo).

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Term pregnancy
* In spontaneous, established labour

Exclusion Criteria:

* Contraindication to vaginal delivery
* Any chronic medical or pregnancy induced illness

Primary outcomes:
measure: To assess whether hyoscine butyl bromide (in the form of Buscopan®) is effective in hastening cervical effacement and dilatation, thus shortening the duration of the first stage of labor.
Secondary outcomes:
measure: To determine whether the use of hyoscine butyl bromide in the first stage of labor has any associated increase in complications, such as an increase in blood loss or rate of Caesarean deliveries, or a decrease in neonatal APGAR scores.
Other outcomes:
Locations:
city: Kingston
country: Jamaica
facility: University of the West Indies
state: Kingston 7
Study officials:
affiliation: University Hospital of the West Indies
name: Leslie A Samuels, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01184690: Single-Operator Versus Dual-Operator Double-balloon Endoscopy in Patients With Small-Bowel Disorders
Official title: Prospective Trial Comparing Single-Operator and Dual-Operator Double-balloon Endoscopy in Patients With Small-Bowel Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Small-Bowel Disorders
Keywords: double-balloon endoscopy
diagnostic yield
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
First posted: 2010-08-19
Enrollment: 80
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Double-balloon endoscopy (DBE) is a new device that allows diagnosis and treatment throughout the entire small intestine. Although the originally described method requires two operators, the investigators have recently developed a method to perform DBE by a single operator. The investigators here assessed the clinical usefulness of this one-person method in comparison to the conventional two-person DBE.


Eligibility criteria: Inclusion Criteria:

1. suspected or known small-bowel disease
2. age: 16-70

Exclusion Criteria:

1. pregnancy
2. coagulation disorders
3. prior surgery of the small bowel and colon

Primary outcomes:
measure: completion whether the complete enteroscopy is achieved?
timeFrame: 2 hours
measure: lesion-discovery
timeFrame: 2 hours
Secondary outcomes:
measure: observation time
timeFrame: 2 hours
measure: Number of Participants with Adverse Events
timeFrame: 2 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai changzheng Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Changzheng Hospital
name: Jian Shi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Changzheng Hospital
name: Bin Shi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Changzheng Hospital
name: Wei-Fen Xie, MD
role: STUDY_DIRECTOR
References:
citation: Araki A, Tsuchiya K, Okada E, Suzuki S, Oshima S, Okamoto R, Kanai T, Watanabe M. Single-operator method for double-balloon endoscopy: a pilot study. Endoscopy. 2008 Nov;40(11):936-8. doi: 10.1055/s-2008-1077545. Epub 2008 Sep 25.
citation: Araki A, Tsuchiya K, Okada E, Suzuki S, Oshima S, Yoshioka S, Yoshioka A, Kanai T, Watanabe M. Single-operator double-balloon endoscopy (DBE) is as effective as dual-operator DBE. J Gastroenterol Hepatol. 2009 May;24(5):770-5. doi: 10.1111/j.1440-1746.2009.05787.x. Epub 2009 Feb 12.
Clinical trial NCT06488690: Early Warning Scores in Pregnant Woman
Official title: Effectiveness of Early Warning Scores: Preoperative Period in Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Complications
Keywords: Early Warning Scores
MEOWS
MEWC
MEWT
Pregnant Women
Maternal Morbidity
Lead sponsor: Suleyman Demirel University
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 304
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Pregnant woman
Primary purpose: PREVENTION

Brief summary: Our study aims to evaluate the use of early warning scores as a screening tool to predict obstetric mortality and morbidity in pregnant women who will undergo cesarean section.

Detailed description: Our study aims to evaluate the use of early warning scores as a screening tool to predict obstetric mortality and morbidity in pregnant women who will undergo cesarean section.

This prospective study included 304 patients undergoing cesarean section at Suleyman Demirel University between April 2022 and April 2023. Physiological parameters were assessed in all 304 pregnant women before the operation. Maternal early warning scores, including modified early obstetric warning score (MEOWS), maternal early warning score (MEWC), and maternal early warning triggers (MEWT), were calculated for each patient. Patients triggering the system were classified as Group 1 (risky patients), while those not triggering the system were classified as Group 2 (risk-free patients).

Eligibility criteria: Inclusion Criteria:

* All patients who are pregnant and undergo cesarean section

Exclusion Criteria:

* None

Primary outcomes:
measure: MEOWS, MEWC and MEWT scores
timeFrame: One year
measure: MEWC score
timeFrame: One year
measure: MEWT score
timeFrame: One year
Secondary outcomes:
measure: APGAR score
timeFrame: One year
measure: Aldrete score
timeFrame: One year
measure: Glasgow Coma Scale
timeFrame: One year
Other outcomes:
Locations:
city: Isparta
country: Turkey
facility: Suleyman Demirel University
state: Merkez
Study officials:
References:
Clinical trial NCT01204190: Investigation of Three Contraceptive Hormone Patches in Regard to Inhibition of Ovulation Following Application Over 3 Treatment Cycles in Healthy, Young Women.
Official title: Multicenter, Open-label, Randomized Study to Evaluate Inhibition of Ovulation During Treatment With Three Transdermal Patch Formulations Containing 0.55 mg Ethinylestradiol (EE) and 2.10 mg Gestodene (GSD) or 0.35 mg EE and 0.67 mg GSD or 0.275 mg EE and 1.05 mg GSD in Healthy Young Female Volunteers Over a Period of 3 Treatment Cycles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Contraception
Keywords: Administration
Cutaneous
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-09-17
Enrollment: 173
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary objective of this trial is to examine whether ovulation is suppressed after use of hormone patches containing different dosages of ethinyl estradiol (EE) and gestodene (GSD) for 3 treatment cycles. To this end, the blood levels of endogenous hormones (hormones produced by your body) will be measured and transvaginal ultrasound examinations will be conducted at regular intervals. In addition, the concentrations of the administered hormones EE and GSD in blood will be determined in regular intervals.

With regard to the tolerability of the hormone patches subjects will be asked regularly how they feel and blood pressure, pulse and body weight will be determined. In addition, blood and urine safety examinations will be conducted at defined timepoints.


Eligibility criteria: Inclusion Criteria:

* Healthy female volunteers
* age 18 - 35 years (smoker not older than 30 years, inclusive)
* ovulatory pre-treatment cycle

Exclusion Criteria:

* Contraindications for use of combined (estrogen/gestodene) contraceptive (e.g. history of venous or arterial thromboembolic disease)
* Regular intake of medication other than Oral Contraception
* Clinically relevant findings (blood pressure, physical and gynecological examination, laboratory examination)

Primary outcomes:
measure: Hoogland score to evaluate the inhibition of ovulation
timeFrame: After 2 months
Secondary outcomes:
measure: Blood level time course of gonadotropins i.e. follicle stimulating hormone (FSH) and luteinizing formone (LH) as well as steroid hormones estradiol and progesterone
timeFrame: After 2 months
measure: Follicle size measured by transvaginal ultrasound examination
timeFrame: After 2 months
measure: Pharmacokinetics of ethinyl estradiol (EE), gestodene (GSD) and sex hormone binding globuline (SHBG)
timeFrame: After 2 months
Other outcomes:
Locations:
city: Berlin
country: Germany
city: Groningen
country: Netherlands
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06727890: Compound Danshen Dripping Pill for Diabetic Microvascular Angina
Official title: The Efficacy and Safety of Compound Danshen Dripping Pill in Patients With Diabetic Microvascular Angina
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Diabetic Microvascular Angina
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the efficacy and safety of Compound Danshen Dripping Pill in patients with diabetic microvascular angina pectoris. Long-term follow-up of 1 year will be performed to evaluate the effect of Compound Danshen Dripping Pill on coronary flow reserve and adverse cardiovascular events in patients with coronary microvascular disease.


Eligibility criteria: Inclusion Criteria:

History of type 2 diabetes ≧5 years; Repeated chest pain attacks with typical exertional angina pectoris or resting angina pectoris attacks; Coronary normal or stenosis \<50%; Ischemic depression in ST segment during resting or exercise; Coronary flow reserve (CFR) of the anterior descending coronary artery \< 2.0, or CFR ≧2.0 but acetylcholine activation test is positive; Subjects or their guardians agreed to participate in this study.

Exclusion Criteria:

Previous myocardial infarction or PCI or CABG treatment; Severe arrhythmia; Refractory hypertension or hypertension accompanied by left ventricular wall thickness \> 12 mm; Familial hypercholesterolemia; Takayasu arteritis, Kawasaki disease or coronary artery malformation; Pregnant or nursing, or having the intention to give birth within one year; Hepatic or renal dysfunction; Allergic to contrast agents or traditional Chinese medicines; Patients who participated in clinical research of other drugs within 3 months before being selected.

Primary outcomes:
measure: Changes of coronary flow reserve measured by three-dimensional echocardiography from baseline to 12 months after follow-up
timeFrame: From baseline to the end of 12-month treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Jinan
country: China
facility: Central Hospital Affiliated to Shandong First Medical University
state: Shandong
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University/Shandong Province Qianfoshan Hospital
state: Shandong
Study officials:
References:
Clinical trial NCT02257190: The Features Behind the Beneficial Effects of Interval-walking
Official title: The Features Behind the Beneficial Effects of Interval-walking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Glycemic control
Exercise
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2014-10-06
Enrollment: 12
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A single bout of Interval-Walking (IW) exercise is superior to energy-expenditure and time-duration matched Continuous Walking (CW) exercise upon improving glycemic control. The reason IW is superior is unknown.

This study will look into whether it is the larger peak intensity during IW or if it is the alternating exercise pattern that is responsible for the larger improvements seen.

Subjects with type 2 diabetes will be included in a crossover, counter-balanced, controlled study, where each subject will undergo three trials. Trials will be identical except the following interventions:

1. One hour of rest (Con)
2. One hour of classical interval walking (repeated cycles of 3 min of fast and 3 min of slow walking; IW3)
3. One hour of fast alternating interval walking (repeated cycles of 1 min of fast and 1 min of slow walking; IW1).

After the interventions subjects will undergo a standardized mixed meal tolerance test, with consecutive measurements of blood glucose, insulin and c-peptide.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus
* Body mass index \> 18 but \< 40 m2/kg
* Agreement to pause antidiabetic medication from 2 days before to after each trial

Exclusion Criteria:

* Pregnancy
* Smoking
* Use of exogenous insulin
* Contraindication to increased levels of physical activity
* Evidence of thyroid, liver, lung, heart or kidney disease

Primary outcomes:
measure: Glycemic control
timeFrame: Within the first 4 hours after the interventions
Secondary outcomes:
measure: Insulin secretion
timeFrame: Within the first 4 hours after the interventions
measure: Insulin sensitivity
timeFrame: Within the first 4 hours after the interventions
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Center for Physical Activity Research (CFAS)
Study officials:
affiliation: Centre for Physical Activity Research, Rigshospitalet, Denmark
name: Kristian Karstoft, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jakobsen I, Solomon TP, Karstoft K. The Acute Effects of Interval-Type Exercise on Glycemic Control in Type 2 Diabetes Subjects: Importance of Interval Length. A Controlled, Counterbalanced, Crossover Study. PLoS One. 2016 Oct 3;11(10):e0163562. doi: 10.1371/journal.pone.0163562. eCollection 2016.