louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00490711: Treatment of Paclitaxel Plus Carboplatin Followed by Gemcitabine Plus Carboplatin for Patients With Epithelial Ovarian Cancer
Official title: Phase II Study of Sequential Therapy With Paclitaxel Plus Carboplatin Followed by Gemzar Plus Carboplatin in the Treatment of Patients With Epithelial Ovarian Cancer FIGO Stages III-IV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Epithelial Ovarian Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2007-06-25
Enrollment: 7
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
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 evaluate the efficacy of paclitaxel and carboplatin followed by gemcitabine and carboplatin therapy for patients with epithelial ovarian cancer.


Eligibility criteria: Inclusion Criteria:

* Histologically verified epithelial ovarian cancer
* FIGO stage III-IV
* Patients with measurable disease. RECIST criteria with GCIG modifications will be used for response and for progression assessment.
* Lesions serving as measurable disease must have the longest diameter of greater than or equal to 20 mm as measured with conventional techniques or greater than or equal to 10 mm with spiral CT scan. Lesions measured by physical examination must have a longest diameter of greater than or equal to 20 mm.

Exclusion Criteria:

* Ovarian tumors with low malignant potential (borderline tumors)
* Non-epithelial ovarian or mixed epithelial. non epithelial tumors (e.g. mixed Mullerian tumors)
* Time between definitive surgery and enrollment into the study is greater than 6 weeks
* Patients who have received previous chemotherapy or radiotherapy

Primary outcomes:
measure: Overall response rate
Secondary outcomes:
measure: Progression-free survival
measure: 2-year survival
measure: Toxicity
measure: Dose intensity
Other outcomes:
Locations:
city: Bratislava
country: Slovakia
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06196411: Effects of Task Oriented Training in Patients With Stroke
Official title: Effects of Task Oriented Training on Cognitive and Motor Functions in Patients With Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Task-oriented training
Bobath training
Motor functions
Cognitive functions
Lead sponsor: Yeditepe University
Sponsor class: OTHER
First posted: 2024-01-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the randomized controlled study is to investigate the effects of task-oriented training on motor and cognitive functions combined with Bobath training in patients with stroke.

Detailed description: Patients who meet the criteria will be informed about the study and volunteers will be included. When initial assessments will be completed, patients will be assigned to one of two possible sequences by simple randomization: study group (SG) or control group (CG).

All volunteers will recieve Bobath training program with the duration of 8 weeks. Additionally, task oriented training will be applied in SG, 5 days a week for 8 weeks.

All patients will be assessed in terms of motor functions and orientation, awareness, spatial perception, visuomotor construction, visual perception, praxis and thinking operations domains of cognitive funtions at the baseline and at the end of the study. Data will be collected from all the patients at baseline and at the end of the study (8 weeks) by the same physiotherapist who also will supervise the exercise sessions.

Eligibility criteria: Inclusion Criteria:

1. Volunteering to participate in the study
2. Be in the age range of 18-80 years
3. Clinical diagnosis of hemiplegia following stroke
4. Time since stroke between 2 and 8 weeks
5. Having stable vital signs
6. A score between 18-23 on the Mini Mental State Examination (MMSE)

Exclusion Criteria:

1. Having global aphasia and/or severe apraxia
2. Diagnosis of dementia or Alzheimer's prior to stroke
3. Participants who discontinued treatment
4. Receiving rehabilitation service before

Primary outcomes:
measure: Mini Mental State Examination (MMSE)
timeFrame: 8 weeks
measure: Dynamic Loewenstein Occupational Therapy Cognitive Assessment- Geriatric Version (DLOTCA-G)
timeFrame: 8 weeks
measure: Functional Independence Measure (FIM)
timeFrame: 8 weeks
measure: Barthel Index (BI)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Eksen Sağlık Inpatient Physical Therapy and Rehabilitation Center
state: Ataşehir
Study officials:
References:
Clinical trial NCT02152111: Hipoenergetic Effect of Diet Associated or Not With the Consumption of Coconut Flour in Women With Overweight
Official title: Effect of Hipoernergetic Diet Combined or Not With Coconut Flour on Overweight Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Cardiovascular Risk Factor
Keywords: Obesity
Coconut flour
Diet quality
Cardiovascular risk factor
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
First posted: 2014-06-02
Enrollment: 86
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to evaluate the effect of weight loss with diet combined coconut flour consumption improvement weight loss and reduction in glucose, cholesterol in obese women.

Detailed description: This is a clinical trial with two groups, one receiving hipoenergetic diet for 180 days and another group with hipoenergetic diet for 90 days, a washout period for another 90 days and another period for another 90 days diet meal plus hipoenergética coconut. In order to assess body mass, waist circumference and neck, assess the lipid profile, glucose and uric acid.

Eligibility criteria: Inclusion Criteria:

women \> 20 years old BMI \>25 Kg/m²

Exclusion Criteria:

Performing diets and / or making use of drugs for the reduction of body weight; Supplements of any kind; Pregnant and lactating women; In use of statins; With voluntary water restriction. -

Primary outcomes:
measure: Anthropometry
timeFrame: 9 months
Secondary outcomes:
measure: Lipid profile
timeFrame: 9 months
measure: Quality of the diet
timeFrame: 9 months
Other outcomes:
Locations:
Study officials:
affiliation: Universidade Federal do Rio de Janeiro
name: Elizabeth P Franco, Nutricionist
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03680911: NAC for Head Trauma-induced Anosmia
Official title: Early N-Acetyl Cysteine Treatment for Head Trauma-induced Anosmia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Anosmia
Head Trauma
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2018-09-21
Enrollment: 7
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: This study will compare administration of N-Acetyl Cysteine (NAC) versus placebo for the treatment of olfactory loss due to head injury. The hypothesis is that treatment with NAC acutely after head injury will result in improved olfactory function


Eligibility criteria: Inclusion Criteria:

* Admitted to Ryder Trauma Center for observation acutely following head injury (i.e. concussion), with documented hyposmia or anosmia by University of Pennsylvania Smell Identification Test (SIT).
* Male or female, aged 18 years or older
* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Ability to take oral medication and be willing to adhere to the NAC regimen
* For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of NAC administration

Exclusion Criteria:

* Severe trauma requiring ongoing inpatient treatment beyond 48 hours
* Pregnancy (based on urine screening) or lactation
* Known allergic reactions to components of NAC, such as Mucomyst
* Currently taking nitrates such as nitroglycerine and/or isosorbide regularly
* Currently taking azathioprine (Imuran) or cyclophosphamide (Cytoxan)
* Known diagnosis of cystinuria (renal condition in which cysteine supplement should be avoided)
* Febrile illness within 1 week
* Treatment with another investigational drug or other intervention within 3 months
* Active sinonasal disease by imaging and/or nasal exam, i.e. rhinosinusitis, nasal polyps
* Adults unable to consent
* Prisoners, employees or subordinates
* Individuals who are not yet adults (infants, children, teenagers). This population is excluded because efficacy has not yet been established in adults.

Primary outcomes:
measure: Olfactory Function
timeFrame: 4 months
Secondary outcomes:
measure: Quality of Life Questionnaire
timeFrame: 4 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University Of Miami, Otolaryngology Department
state: Florida
Study officials:
affiliation: University of Miami
name: Roy Casiano, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06815393: COMPARISON of the EFFECT of TWO DIFFERENT ANALGESIS TECHNIQUES in ABDOMINAL HYSTERECTOMY
Official title: Comparison of the Analgesic Effect of Intrathecal Morphine and Bilateral Transversus Abdominis Plane Block in Patients Undergoing Elective Abdominal Hysterectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Abdominal Hysterectomy
Keywords: abdominal hysterectomy
intratechal morphine
transversalis fascia plane block
Lead sponsor: Ataturk Training and Research Hospital
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Hysterectomy is one of the most commonly performed surgical procedures after cesarean section in many countries worldwide, especially among women of reproductive age. Postoperative pain is typically managed with oral and parenteral narcotics. Patient-controlled analgesia (PCA) is an effective pain management method that provides advantages such as faster pain relief, better dosage control, and elimination of the need for timer adjustments. Facilitating the recovery process and optimizing postoperative pain management are crucial components of perioperative care. To minimize systemic opioid requirements and opioid-related side effects, multimodal analgesia combining local anesthesia, peripheral, and non-opioid analgesics has become increasingly popular.


Eligibility criteria: Inclusion Criteria:

* Women aged between 18 and 65 years classified as ASA 1 and ASA 2.

Exclusion Criteria:

* Patients with allergies to the active substance, those with severe liver or renal insufficiency, a history of long-term nonsteroidal anti-inflammatory drug (NSAID) and opioid analgesic use, a history of gastrointestinal bleeding, peptic ulcer or inflammatory bowel disease, a history of diabetes or other neuropathic conditions, preoperative atrioventricular block and bradycardia, underlying serious respiratory diseases, a history of psychiatric disorders, patients classified as ASA stage 3 or higher, patients weighing less than 40 kg, patients unable to use the patient-controlled analgesia (PCA) device, and patients who need to discontinue the study medication during surgery for any reason will be excluded from the study

Primary outcomes:
measure: Postoperatve Opioid Consumption
timeFrame: postoperatively 24 hours
Secondary outcomes:
measure: Postoperative Pain Scores at movement and rest
timeFrame: postoperatively 24 hours
measure: Quality of recovery 24 hours after the surgery assessed using QoR-40 questionnaire
timeFrame: postoperative 24 hour
measure: Advers Event
timeFrame: postoperative 24 hour
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University
state: Yakutiye
Study officials:
References:
Clinical trial NCT03032393: The Effect of Power Posing on Timed Up and Go Test Score
Official title: The Effects of Posture on Timed up and go
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Youngstown State University
Sponsor class: OTHER
First posted: 2017-01-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study determines the effects of posture on time up and go test. Half of the subjects will assume a high-power posture, while the other half will assume a low-power posture.

Detailed description: Subjects in the experimental group were instructed to stand with hands on their hips, elbows pointing out and feet approximately one foot apart for 20 seconds. Subjects in the control group were instructed to stand with hands and arms wrapping around the torso and feet together for 20 seconds. Timed Up and Go test was administered using an OmniVR™ Virtual Rehabilitation System before and after the postural intervention

Eligibility criteria: Inclusion Criteria:

* male or female, age 18 to 65, with all 4 extremities intact, and ability to stand still for 20 seconds.

Exclusion Criteria:

* unable to stand with their feet together or one foot apart for at least 20 seconds, unable to wrap their arms around their torso or keep their hands on their hips for 20 seconds, unable to perform sit to stand transfer and ambulation independently, and cognitive impairments that interfere with the experimental procedures.

Primary outcomes:
measure: Timed up and go Test
timeFrame: Up to 3 minutes during each Timed up and go Test. Twice (pre and post the postural intention) at the same session (day).
Secondary outcomes:
Other outcomes:
Locations:
city: Youngstown
country: United States
facility: Youngstown State University
state: Ohio
Study officials:
affiliation: Youngstown State University
name: Michael Hripko
role: STUDY_DIRECTOR
References:
Clinical trial NCT06466993: Influence of Relaxing Breathing Before Each Station of an Objective Structured Clinical Examination
Official title: Influence on Performance of Relaxing Breathing During Rotation Pause Before Each Station of an Objective Structured Clinical Examination for Fifth Year Medical Students
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Performance Anxiety
Stress
Coping Skills
Lead sponsor: Claude Bernard University
Sponsor class: OTHER
First posted: 2024-06-20
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized controlle monocentric
Primary purpose: OTHER

Brief summary: SObjective and Structured Clinical Examinations (OSCEs) has been incorporated recently in the certification process as a final national undergraduate ranking examination. This exam is an additional major stressor for medical students.

The aim of this study was to compare the efficiency on stress reduction of a standardized relaxing breathing occuring during rotation of the OSCE stations just before the start of the next upcoming OSCE station, in medical student, during the OSCE.

Detailed description: Stress generated during the curriculum might have deleterious effects on the wellbeing and the health of medical students. Objective and Structured Clinical Examinations (OSCEs) has been incorporated recently in the certification process as a final national undergraduate ranking examination. This exam is an additional major stressor for medical students.

Stress coping strategies could be implemented to help them better prepare for this examination. The aim of this study was to compare the efficiency on stress reduction of a standardized relaxing breathing as a coping interventions occuring during rotation of the OSCE stations just before the start of the next upcoming OSCE station, in medical student, during the OSCE.

Eligibility criteria: Inclusion Criteria:

* all volontary medical students of the second cycle that came for their exam during the sessions of June 2024 from the University of Lyon (Medecine ESt)

Exclusion Criteria:

* no exclusion criteria

Primary outcomes:
measure: PERFORMANCE
timeFrame: obtained seven days after the objectif structured clinical examination
Secondary outcomes:
measure: Mean Difference of Inner Resource
timeFrame: Two times : 10 minutes before objectif structured clinical examination (before training of intervention) and just 2 minutes after training of the intervention)
measure: Mean difference of perceived impact of the intervention on performance
timeFrame: Just five minutes after the objectif structured clinical examination
Other outcomes:
Locations:
Study officials:
affiliation: Lyon Est Medical Center Lyon 1 University
name: Gilles Rode, MD PhD
role: STUDY_CHAIR
affiliation: Lyon Est Medical Center Lyon 1 University
name: Evan Gouy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lyon Est Medical Center Lyon 1 University
name: Marion Cortet, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03954093: Paired Acute Invasive/Non-invasive Stimulation Trial
Official title: Paired Transcranial Direct Current Stimulation/ Dorsal Root Ganglion Stimulation Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2019-05-17
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Chronic pain patients with implanted dorsal root ganglion stimulators will be randomized to receive transcranial direct current stimulation (tDCS) to the motor cortex, magneto-encephalographically (MEG) localized stimulation or sham stimulation to identify therapeutic efficacy of paired central and peripheral neuromodulation.


Eligibility criteria: Inclusion Criteria:

* Patients who are willing and able to give consent to the study.
* Male or Female, aged 18 years or above with diagnoses of chronic pain.
* Treatment includes Spinal Cord Stimulation, Dorsal Root Ganglion stimulation, or peripheral analgesic stimulation.

Exclusion Criteria:

* Patients who do not wish to be in the study.
* Patients with metallic intracranial implants.
* Patients with extreme language barrier that cannot understand the purpose of the study despite the use of an interpreter

Primary outcomes:
measure: Change in pain scores: 21-point pain scale rating
timeFrame: Immediately after 30 minutes of transcranial direct current stimulation
Secondary outcomes:
measure: Changes in EEG recordings
timeFrame: Immediately after 30 minutes of transcranial direct current stimulation
measure: Changes in Facial Expression Recognition Performance
timeFrame: Immediately after 30 minutes of transcranial direct current stimulation
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
state: Oxfordshire
Study officials:
affiliation: University of Oxford
name: Alex Green, FRCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03138785: UVX as an Adjuvant in the Treatment of Fungal Keratitis
Official title: UVX as an Adjuvant in the Treatment of Fungal Keratitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Treatment
Lead sponsor: Farabi Eye Hospital
Sponsor class: OTHER
First posted: 2017-05-03
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, investigators want to find the effect of adjuvant collagen cross-linking in the treatment of fungal keratitis


Eligibility criteria: Inclusion Criteria:

* fungal keratitis documented by culture or confocal scanning without any previous treatment

Exclusion Criteria:

* Previous treatment
* Thinning at presentation
* Perforation
* Associated with other microbial or viral keratitis

Primary outcomes:
measure: time of complete healing (days)
timeFrame: 180 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Davis SA, Bovelle R, Han G, Kwagyan J. Corneal collagen cross-linking for bacterial infectious keratitis. Cochrane Database Syst Rev. 2020 Jun 17;6(6):CD013001. doi: 10.1002/14651858.CD013001.pub2.
Clinical trial NCT03314285: Evaluation of Sleep Quality in Patients With Chronic Neck Pain
Official title: Placebo-Controlled Trial of Evaluation of Sleep Quality in Patients With Chronic Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Sleep
Keywords: Cervicalgia
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2017-10-19
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study aimed to investigate the effect of chronic neck pain on sleep quality and to determine the factors that may be related to sleep disturbance.

Detailed description: It is thought that chronic neck pain affects sleepiness negatively. However, there are no studies on chronic neck pain and sleep quality. In this study, we would like to determine whether there is a link between chronic neck pain and sleep quality and the factors that may be related.

Eligibility criteria: Inclusion Criteria:

* Patient has chronic mechanical neck pain for at least 3 months and without radicular pain
* Patient's visual analogue scale score is 3 and over

Exclusion Criteria:

* History of neurological deficit
* History of cervical stenosis, cervical surgery, spondylolisthesis, scoliosis
* History of central or peripheral nervous system disorders
* History of inflammatory neck pain
* Pregnant or breast feeding
* History of fibromyalgia disease
* History of severe osteoporosis or osteomalacia
* History of infectious, malignancy, and active psychiatric disease
* Noncooperative
* Patient has chronic pain in a region other than the neck region

Primary outcomes:
measure: Pittsburg Sleep Quality Scale
timeFrame: 30 day
Secondary outcomes:
measure: Demographic Data
timeFrame: 30 day
measure: Pain Severity
timeFrame: 7 day
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gaziosmanpasa Taksim Research and Education Hospital
Study officials:
affiliation: Department of Physical Medicine and Rehabilitation, Gaziosmanpasa Taksim Training and Research Hospital
name: Alper Mengi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: