louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05133167: Balloon Tamponade Vs B-Lynch In Placenta Previa
Official title: Comparison of Efficacy of Surgical Interventions (Balloon Tamponade Versus B-lynch Suture) to Prevent Postpartum Hemorrhage in Patients With Placenta Previa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Placenta Previa
Lead sponsor: CMH Jhelum
Sponsor class: OTHER
First posted: 2021-11-24
Enrollment: 60
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients were allocated to group A and B. In group A, balloon tamponade (using Foley catheter 28 Fr) was used intra-operatively to prevent post-partum hemorrhage. In group B, B lynch suture was used intra-operatively to prevent post-partum hemorrhage.

Detailed description: After approval from hospital ethical committee, patients fulfilling the inclusion \& exclusion criteria were recruited after taking informed written consent for surgery. Patients were allocated to group A and B using computer generated random sample allocation.

In group A, balloon tamponade (using Foley catheter 28 Fr) was used intra-operatively to prevent post-partum hemorrhage. Post-operative blood loss within first 24 hours was estimated by measuring the amount of blood collected in Foley balloon tamponade bag, in milliliters.

In group B, B-lynch suture was used intra-operatively to prevent post-partum hemorrhage. Post-operative blood loss within first 24 hours was estimated by the weight difference of the pads before and after patient use (1-gram weight difference = 1 ml blood volume lost). Mean blood loss within first 24 hours post procedure, was compared in both the groups for outcome measurement.

Eligibility criteria: Inclusion Criteria:

1. Singleton pregnancy
2. Late Third Trimester pregnancy (35+ weeks to 39 weeks)
3. Placenta Previa confirmed by ultrasonography
4. Elective Caesarean Section.

Exclusion Criteria:

1. Multiple gestation
2. Placenta accreta Spectrum (accrete/increta/percreta)
3. Bleeding diathesis
4. Other Causes of Post-Partum Hemorrhage i.e. Uterine atony, Genital tract tears, Retained Products of Conception etc.
5. Serious medical or surgical diseases.

Primary outcomes:
measure: Mean blood loss
timeFrame: 24 hours post procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Jhelum
country: Pakistan
facility: CMH
state: Punjab
Study officials:
affiliation: Anesthesiologist
name: Muhammad Awais Qarni
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01699867: Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part A)
Official title: Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part A)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: lumpectomy
breast cancer
optical coherence tomography
tumor margin
imaging
Lead sponsor: Diagnostic Photonics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Johns Hopkins University
First posted: 2012-10-04
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with breast cancer undergoing lumpectomy

Brief summary: This multi-center, prospective, open label study analyzed specimens from fifty subjects at two study sites. Patients scheduled to undergo breast-conserving surgery were recruited in accordance with the inclusion and exclusion criteria. The study period per subject was the time it took to assess the ex vivo breast tissue sample using the study device. Image review was conducted after surgery and compared to the margin status findings in the post-operative pathology report.


Eligibility criteria: Inclusion Criteria:

1. Women 18 years of age or older
2. Signed informed consent form
3. Women who have been histologically diagnosed with carcinoma of the breast prior to surgery
4. Patients planning breast preservation and undergoing lumpectomy (partial mastectomy) procedure

Exclusion Criteria:

1. Multicentric disease (histologically diagnosed cancer in two different quadrants of the breast)
2. Neoadjuvant systemic therapy
3. All T4 tumors
4. Previous radiation in the operated breast
5. Prior surgical procedure in the same quadrant
6. Implants in the operated breast
7. Pregnancy
8. Lactation
9. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study

Primary outcomes:
measure: Patients With All Positive Margins Correctly Identified With the Device
timeFrame: one week after surgery
measure: Number of Margins With False Positive Device Readings
timeFrame: one week after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Annapolis
country: United States
facility: Anne Arundel Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Lisa K Jacobs, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00514267: An Open-Label Study of YM155 + Docetaxel in Subjects With Advanced Hormone Refractory Prostate Cancer and Other Solid Tumors
Official title: A Phase I/II Multicenter, Open-Label Study of YM155 Plus Docetaxel in Subjects With Advanced Hormone Refractory Prostate Cancer and Other Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
Tumors
Keywords: Prostate Cancer
HRPC
Hormone Refractory Prostate Cancer
YM155
Treatment Outcome
Solid Tumors
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2007-08-09
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the feasibility and safety of administering YM155 in combination with docetaxel

Detailed description: This clinical trial is designed to include two parts:

Part 1: Assessment of feasibility and safety of administering YM155 in combination with docetaxel and prednisone in subjects with hormone refractory prostate cancer (HRPC) \[ ENROLLMENT COMPLETED \]

Part 2: Assessment of feasibility and safety of administering YM155 in combination with docetaxel in subjects with solid tumors (except HRPC).

This registration has been updated to reflect the design requirements of PART 2.

Eligibility criteria: Inclusion Criteria:

Part 1:

* Male subjects with histologically or cytologically confirmed adenocarcinoma of the prostate with clinical or radiological evidence of metastatic disease.

Part 2:

* Subjects with histologically and cytologically confirmed solid tumors with measurable disease (except HRPC).

Exclusion Criteria:

* Radiation therapy within 4 weeks of the start of study drug

Primary outcomes:
measure: Occurrence of dose limiting toxicities (Part 1: Subjects with HRPC)
timeFrame: 2 cycles
measure: Occurrence of dose limiting toxicities (Part 2: Subjects with other solid tumors)
timeFrame: 1 cycle
Secondary outcomes:
measure: Assessment of safety and efficacy
timeFrame: 10 cycles
measure: Assessment of pharmacokinetics
timeFrame: Part 1 only
Other outcomes:
Locations:
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Astellas Pharma Global Development
name: Central Contact
role: STUDY_DIRECTOR
References:
Clinical trial NCT01896167: Migraine With Aura Inducing Characteristics and Effects on the Cerebral Arteries and Blood Flow by Hypoxia
Official title: Study of Migraine With Aura Inducing Characteristics and Effects on the Cerebral Arteries by Hypoxia in a Humane Experimental Migraine Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headache
Migraine
Aura
Keywords: Headache
Migraine
Aura
Cerebral hemodynamics
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2013-07-11
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: In this study the investigators will investigate the following hypothesis

* that hypoxia induce migraine headache and migraine aura
* the aura phase is associated with a spreading reduction in cerebral blood flow
* the migraine headache is associated with dilatation of intra- and extracerebral arteries
* the migraine headache is associated with changes in brain metabolism
* the pre-ictal stage of a migraine attack with aura is associated with specific patterns in neural activity.

Detailed description: To investigate migraine with aura symptoms during and after hypoxia.

With magnetic resonance imaging the investigators will investigate changes in

* regional cerebral blood flow (rCBF)
* resting state functional connectivity
* circumference of the middle cerebral artery(MCA), internal carotic artery, superficial temporal artery, medial meningeal artery, external carotic artery
* brain metabolism

And compare these changes with a aged match healthy control group.

Eligibility criteria: Inclusion Criteria:

Migraine with aura patients and Helthy volunteers as controls:

* Aged 18-40
* 50-100 kg

Exclusion Criteria:

* Tension type headache more than 5 days/month
* Other primary headaches
* Daily medication except contraceptives
* Drug taken within 4 times the halflife for the specific drug except contraceptives
* Pregnant or lactating women
* Headache or migraine attack within the last 48 hours before start of trial
* Hypertension
* Hypotension
* Respiratory or cardiac disease
* smoking

Extra exclusion Criteria for healthy volunteers:

* migraine at present or earlier in life
* parents, sibling or children who suffer or have suffered from migraine

Primary outcomes:
measure: Headache and aura
timeFrame: 24 h
Secondary outcomes:
measure: artery circumference
timeFrame: Baseline, 120 and 200 min
measure: Cerebral blood flow
timeFrame: Baseline, 120 and 200 min
measure: BOLD response in visual cortex
timeFrame: Baseline, 170 min and 220 min
measure: Brain metabolism
timeFrame: Baseline, 180 min and 230 min post hypoxia
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Nanna Arngrim
Study officials:
affiliation: Department of Neurology, Glostrup Hospital
name: Nanna Arngrim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02786667: Non Motors Aspects in De Novo Parkinson's Disease
Official title: Non Motors Aspects in De Novo Parkinson's Disease: Clinical and Physiopathological Description; Dopamine Agonist Treatment Effects.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Parkinson Disease
Apathy
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2016-06-01
Enrollment: 199
Sex: ALL
Minimum age (years): 30
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinical description and pathophysiological study of recently diagnosed untreated patients with Parkinson's Disease.

Effect of a dopamine agonist (rotigotine) on apathy in de novo patients with Parkinson disease: A controlled, randomized, double blind study.

Detailed description: This study aims to show the impact of a treatment with a D2/D3 receptor-specific dopamine agonist on the hypo-dopaminergic syndrome and quality of life of patients with de-novo Parkinson's disease.

The study consists of three parts:

1. The first part consists of a detailed clinical description of these patients, focusing on neuropsychological symptoms. The objective is to describe patients with and without apathy and hypo-dopaminergic syndrome.
2. From this population, a small number of patients with and without hypo-dopaminergic syndrome will be selected in order to compare serotoninergic and dopaminergic denervation by positron emission tomography (PET).
3. In patients with hypo-dopaminergic syndrome the motivational effects of a dopamine agonist will be tested in a randomized, double-blind, placebo-controlled study.

We hypothesize a significant improvement of apathy in the rotigotine group versus placebo

Eligibility criteria: Inclusion Criteria:

* Patients with Parkinson disease without treatment for Parkinson disease
* Recent diagnosis (\< 2 years)
* Without cognitive troubles

Exclusion Criteria:

* Patients with cognitive troubles
* Treated patients with L-Dopa or Dopamine agonists
* Other severe illness
* Pregnant or parturient woman

Primary outcomes:
measure: Change of LARS (Lille Apathy Rating Scale) score in the rotigotine versus placebo group
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital of Grenoble
Study officials:
affiliation: University Hospital, Grenoble
name: Anna Castrioto, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02683967: The Impact of Acupuncture on the Success Rates of IVF (In Vitro Fertilisation) Treatments
Official title: The Impact of Acupuncture on the Success Rate of IVF Treatments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Lead sponsor: Homerton University Hospital NHS Foundation Trust
Sponsor class: OTHER
First posted: 2016-02-17
Enrollment: 184
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The trial aims to investigate whether acupuncture has an effect in increasing clinical pregnancy (pregnancy that is confirmed by a scan) and live birth rates on women undergoing IVF treatment.

Detailed description: Failing to conceive naturally poses significant stress to the infertile couple. It creates a feeling of failure and frustration. It has been found that the use of complementary therapies makes women feel empowered, with a sense of regaining control of the body.

The popularity of acupuncture is increasing. A significant proportion of couples having fertility treatment, especially IVF (In-Vitro Fertilisation) ask their clinician about using acupuncture and some patients undergo acupuncture privately without reporting to their clinicians.

The effectiveness of acupuncture on IVF has been extensively researched; however the results are varied and not conclusive. This is due to previous studies varying significantly in their study design, acupuncture timing and the final outcome measure. As a result of the difference in the studies it is not clear whether acupuncture is beneficial regarding IVF success rates and whether it should be offered to women undergoing IVF.

Eligibility criteria: Inclusion Criteria:

* Women under the age of 43 years with a BMI of less than 30 undergoing 1st or no more than their 2nd failed fresh IVF or ICSI cycle.

Exclusion Criteria:

* Those women undergoing frozen embryo replacement cycle or receiving donor eggs, BMI \> 30 or currently having acupuncture/ any other form of CAM, having contraindication to acupuncture like those with HIV, Hep C will be excluded.

Primary outcomes:
measure: Live birth rate
timeFrame: 18 months
Secondary outcomes:
measure: Clinical pregnancy rate
timeFrame: 18 months
measure: Multiple pregnancy
timeFrame: 9 months
measure: Quality of life
timeFrame: 9 months
Other outcomes:
Locations:
Study officials:
affiliation: NHS Honorary Contract
name: Karin Gillerman
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00818467: UVB Light and Sunscreen
Official title: 3% Dihydroxyacetone (DHA or Sunless Tanning Agent) Inhibits Vitamin D Production in the Skin in Response to Ultraviolet Light
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vitamin D Status
Keywords: Skin tone
Vitamin D
Lead sponsor: Creighton University
Sponsor class: OTHER
Collaborators: name: The UV Foundation
First posted: 2009-01-07
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients need vitamin D which is normally produced in the skin in response to ultraviolet light from the sun. Vitamin D is important for calcium absorption and good bone health. Physicians have been using sunscreens to protect patients from skin cancer and the aging effects of sunlight for a least a half a century. Dermatologists have promoted sunscreen use to restrict sunlight exposure especially in white Caucasians. If this behavior is done 100% of the time when outdoors individuals may suffer from vitamin D deficiency. It is impossible to influence persons' behavior to wear sunscreens all the time when outdoors. With the use of sunless tanning agent (DHA), once a week, we can obtain a continuous sunscreen in the top layer of the skin that will not wash off, can't be removed with soap and water, or removed by perspiration. Under these circumstances we can answer the scientific question, will sunscreen use inhibit the production of vitamin D in the skin?


Eligibility criteria: Inclusion Criteria:

* males or females
* ages 19-50 with less than 16 oz milk per day
* less than 10 hours of sun per week
* no Vitamin D supplements
* no anticonvulsants
* no barbiturates
* no steroids
* no meds that increase photosensitivity
* no granulomatous disease
* no liver or kidney disease
* no history of skin cancer
* BMI less than 30
* skin types I \& II

Exclusion Criteria:

* None

Primary outcomes:
measure: To measure the response of 25(OH)D to 40 milliJoules of UV-B light in white Caucasians with melanoidins-sunscreen from 3% DHA in comparison to the response of control subjects who have not used 3% DHA.
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
Study officials:
affiliation: Creighton University
name: Laura A Armas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02804867: Spot Depression Study
Official title: A Blood Test to Identify Persons at Risk of Developing Depression or Bipolar Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorder
Depressive Disorder
Lead sponsor: University of Cambridge
Sponsor class: OTHER
First posted: 2016-06-17
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants recruited using flyers, emails, and online recruitment.

Brief summary: This study aims to identify signs of depression and bipolar disorder by measuring changes of certain molecules (biomarkers) that can be detected in dried blood spots. Our goal is to use these biomarkers to develop a diagnostic test to enable early treatment, which can lead to better patient outcomes.

Detailed description: Bipolar disorder and major depression are serious mental health conditions that have a devastating impact on patients, their families and friends, and society. Currently, no laboratory test exists for these disorders. We are trying to develop a molecular test based on blood spots (small spots of blood obtained from patients' fingertips that have been dried on special paper). Volunteers take part by filling out the questionnaire at www.spot-depression.org. They may then be selected to provide a dried blood spot, which can be collected at home using a kit that will be mailed to their address.

Eligibility criteria: Inclusion Criteria:

* Residing in the United Kingdom
* Over 18 years of age

Exclusion Criteria:

* Pregnant or breastfeeding
* Presence of blood-borne infection

Primary outcomes:
measure: Comparison of protein concentrations in dried blood spots between patient groups and controls
timeFrame: Baseline (at enrollment); no follow-up
measure: Assessment of classification accuracy of protein concentrations in dried blood spots for distinguishing between bipolar disorder and depression
timeFrame: Baseline (at enrollment); no follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Jordan Ramsey
state: Cambridgeshire
Study officials:
affiliation: Principal Investigator
name: Sabine Bahn, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03944967: Postoperative Remote Monitoring of Vital Signs in Older Cardiac Surgery Patients
Official title: Postoperative Remote Monitoring of Vital Signs in Older Cardiac Surgery Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoxemia
Respiratory Failure
Arrythmia
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
First posted: 2019-05-10
Enrollment: 71
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes 100 patients ≥70 years undergoing elective cardiac surgery.

Brief summary: A significant number of elderly patients experience a complication after cardiac surgery. This study aims to determine if postoperative remote monitoring of vital signs can be used to identify medicatie risk factors for vital sign deterioration in older cardiac surgery patients.

* Single center pilot study.
* 100 older patients undergoing cardiac surgery.
* Continuous remote monitoring of vital signs after ICU discharge
* Main study endpoint is vital sign deterioration.

Detailed description: Cardiac surgery in elderly patients aims to improve functional capacity and overall survival but may also precipitate major morbidity and mortality. Despite major improvements in the safety of anesthesia and surgery a significant number of elderly patients experience a complication after cardiac surgery.

To determine if postoperative remote monitoring of vital signs can be used to identify medication risk factors for vital sign deterioration in older cardiac surgery patients..

* Single center pilot study.
* 100 older patients undergoing cardiac surgery.
* Continuous remote monitoring of vital signs starts after ICU discharge
* PR, RR and SpO2 will be continuously monitored in all patients.
* Patients and healthcare personnel are blinded for monitoring results.
* Main study endpoint is vital sign deterioration.

The study population includes 100 patients ≥70 years undergoing elective cardiac surgery.

Eligibility criteria: Inclusion Criteria:

* ≥70 years undergoing elective cardiac surgery.

Exclusion Criteria:

-

Primary outcomes:
measure: Hypoxemia
timeFrame: Three consecutive days after ICU discharge
measure: Respiratory deterioration
timeFrame: Three consecutive days after ICU discharge
measure: Arrythmia
timeFrame: Three consecutive days after ICU discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: St Antonius hospital
state: Utrecht
Study officials:
References: