louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04646863: Effect of Class IV Laser Therapy and Pilates Exercises on Bone Density and Pain in Primary Osteoporosis: A Randomized Controlled Trial
Official title: Effect of Class IV Laser Therapy and Pilates Exercises on Bone Density and Pain in Primary Osteoporosis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Keywords: Osteoporosis, LLLT, multiwave locked system laser, Physical therapy modalities, DEXA, Pilates exercises
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2020-11-30
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the current study was to investigate the effect of class IV laser therapy and Pilates exercises on bone density in Osteoporosis.Sixty patients with osteoporosis (T-score values below -2.5) in lumbar spine with no evidence of vertebral compression fractures were recruited from October 6 University Hospital and Kaser El-aini Hospital, Cairo - Egypt from February 2019 to November 2019. Their age ranged from 40 to 60 years old. Patients with a history of tumors, ovariectomy, heart disease, renal failure, disc prolapse, or any trauma to the back area were excluded from the study

Detailed description: They were allocated randomly into three groups: Group A consists of 20 patients received a multiwave locked system laser, group B consists of 20 patients received Pilates exercises and group C consists of 20 patients received a multiwave locked system laser and Pilates exercises. Patients with a history of tumors, ovariectomy, heart disease, renal failure, disc prolapse, or any trauma to the back area were excluded from the study. All patients who participated in the current study did not intake any medications to accelerate bone density like vitamin D or calcium. The randomization method was applied by asking each patient to choose a piece of paper that the (A), (B), or (C) letter was written. (A) considered the LLLT group, (B) considered the Pilates exercise group, while (C) considered the LLLT and Pilates exercises group. Both patients, the examiner, and therapist were blinded from the selection process.

Eligibility criteria: Inclusion Criteria:

* Patients with osteoporosis (T-score values below -2.5)

Exclusion Criteria:

* Patients with a history of tumors, ovariectomy, heart disease, renal failure, disc prolapse, or any trauma to the back area

Primary outcomes:
measure: DEXA
timeFrame: 8 weeks
measure: Numeric pain rating scale (NPRS)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Bassam
Study officials:
References:
Clinical trial NCT06507163: The Effect of Breathing Exercise Applied With Incentive Spirometer
Official title: The Effect of Breathing Exercise Applied With Incentive Spirometer on Pain, Anxiety, Comfort and Physiological Parameters Before and After Surgery in Cardiac Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breathing Exercises
Cardiac Surgery
Incentive Spirometry
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2024-07-18
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: It was conducted as a single-center, prospective, randomized controlled experimental study. Data were collected with the Introductory Information Form, Numerical Rating Scale, Physiological Parameters Follow-up Form and General Comfort Scale.

Detailed description: It was conducted as a single-center, prospective, randomized controlled experimental study. Data were collected with the Introductory Information Form, Numerical Rating Scale, Physiological Parameters Follow-up Form and General Comfort Scale.The study was conducted in three groups. Individuals in the intervention-1 group were asked to perform breathing exercises with IS in addition to the routine practices of the clinic for 5 days in the postoperative period. Individuals in the intervention-1 group were asked to perform breathing exercises with IS in addition to the routine practices of the clinic for a total of 10 days, 5 days in the preoperative period and 5 days in the postoperative period. Individuals in the control group were given only the routine practice of the clinic.

Eligibility criteria: Inclusion Criteria:

* Able to communicate in Turkish,
* undergoing cardiac surgery,
* no pain in the preoperative period (0 pain according to VA),
* have no problems with vision, hearing or speech,
* individuals who agreed to participate in the study were included.

Exclusion Criteria:

* Using psychiatric medication,
* Using immunosuppressive medication until 30 days before surgery,
* with neuromuscular disorders,
* having rheumatic disease,
* have had pulmonary surgery before,
* with cerebrovascular injury,
* diagnosed with cardiovascular instability or aneurysm,
* Diagnosed with COPD,
* individuals who do not volunteer to participate in the study

Primary outcomes:
measure: Pain level
timeFrame: postop 1st and postop 5th day
measure: Anxiety level
timeFrame: postop 1st and postop 5th day
measure: Comfort level
timeFrame: postop 1st and postop 5th day
measure: Partial oxygen pressure (PaO2)
timeFrame: postop 1st and postop 5th day
measure: Forced Vital Capacity (FVC)
timeFrame: postop 5th day
Secondary outcomes:
Other outcomes:
Locations:
city: Talas
country: Turkey
facility: Sevda Korkut
state: Kayseri
Study officials:
affiliation: TC Erciyes University
name: SEVDA KORKUT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02512263: Assessment of Adherence and Efficiency of a Home-based Training Program on Muscular Strength, Endurance and Qol for Colon Cancer Patients
Official title: Assessment of Adherence and Efficiency of a Home-based Training Program on the Muscular Strength, the Endurance and the Quality of Life for Colon Cancer Patients Treated by Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colon Cancer
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2015-07-30
Enrollment: 50
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: The purpose is to assess the adherence and the efficiency of a home-based training program on muscular strength, endurance and the quality of life, fatigue, physical activity, anxiety and depression for colon cancer patient treated by chemotherapy.

Detailed description: It's a 9-weeks experimentation with 4 moments (every 3 weeks) to do the tests.

Eligibility criteria: Inclusion Criteria:

* Colon cancer patients treated by chemotherapy adjuvant

Exclusion Criteria:

* Patients who have metastasis
* Patients hospitalized during the experimentation
* Patients who have major orthopedic or neurologic problems

Primary outcomes:
measure: Muscular strength measured by Microfet
timeFrame: 15 minutes
Secondary outcomes:
measure: Quality of life measured by questionnaire
timeFrame: 3 minutes
measure: Fatigue measured by questionnaire
timeFrame: 3 minutes
measure: Physical activity measured by questionnaire
timeFrame: 3 minutes
measure: Anxiety measured by questionnaire
timeFrame: 3 minutes
measure: Exercise tolerance measured by Six minute walking test
timeFrame: 6 minutes
measure: Depression measured by questionnaire
timeFrame: 3 minutes
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
Study officials:
References:
Clinical trial NCT01928563: Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between Udenafil and Dapoxetine
Official title: A Randomized, Open-label, Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Udenafil and Dapoxetine in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy Male Subjects
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Dong-A ST Co., Ltd.
First posted: 2013-08-26
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is designed to investigate the pharmacokinetic drug interaction between Udenafil and Dapoxetine in healthy male subjects

Design : Randomized, open-label, 3-treatment, 6-sequence, 3-period crossover study

Investigational Product : Udenafil, Dapoxetine


Eligibility criteria: Inclusion Criteria:

* Male volunteers in the age between 20 and 45 years old at screening
* Body mass index(BMI) in the range of 19 to 27 ㎏/㎡
* Sitting position blood pressure down to meet the criteria at the time of screening (90mmHg≤Systolic blood pressure≤140mmHg)

Exclusion Criteria:

* History of clinically significant disease or kidney, liver and biliary system, digestive system, respiratory, musculoskeletal, endocrine, neurological psychiatric blood and tumor system, cardiovascular system, etc.
* History of gastrointestinal diseases or gastrointestinal operation which might affect the study drug absorption
* Clinically significant hypersensitivity or with a history of hypersensitivity reactions to Udenafil, Dapoxetine ingredients that included elements of the same family of drugs, or other medications
* ≥ 1.5 fold of normal upper limit(UNL) in the level of ALT, AST
* Alcohol, excessive intake (\>21 units/week)
* Excessive smoker (\>10 cigarette/day)

Primary outcomes:
measure: Cmax and AUClast of Udenafil and Dapoxetine
timeFrame: Blood gathering point : 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 32, 48h (each period)
Secondary outcomes:
measure: AUC0-00, Tmax, T1/2β of Udenafil and Dapoxetine AUClast, Cmax, Tmax, t1/2β of DA-8164(major metabolite of Udenafil) and Desmethyl dapoxetine(major metabolite of Dapoxetine)
timeFrame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 32, 48h (each period)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-gu
Study officials:
affiliation: Asan Medical Center
name: Kyun-Seop Bae, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03125863: Acute Hemostasis Following the Use of the AQUABEAM® System for the Treatment of Benign Prostatic Hyperplasia
Official title: Acute Hemostasis Following the Use of the AQUABEAM® System for the Treatment of Benign Prostatic Hyperplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Keywords: Image-guided
BPH
Aquablation
AQUABEAM
LUTS
Tissue resection
Robotics
Lead sponsor: PROCEPT BioRobotics
Sponsor class: INDUSTRY
First posted: 2017-04-24
Enrollment: 21
Sex: MALE
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A single-arm prospective, interventional clinical trial to evaluate the safety and performance of obtaining hemostasis with commercially approved catheters following prostate resection using the AquaBeam for treatment of LUTS resulting from BPH.

Detailed description: PROCEPT BioRobotics has developed the AquaBeam, a personalized image-guided waterjet resection system that utilizes a high-velocity saline stream to resect and remove prostate tissue in males suffering from Lower Urinary Tract Symptoms (LUTS) due to BPH. The AquaBeam System is intended for the resection and removal of prostate tissue in patients experiencing LUTS. The primary objective of the study is to evaluate the safety and performance of obtaining hemostasis with commercially approved catheters following prostate resection using the AquaBeam. The time frame of the study is 7 days. Up to 30 participants will be included in this single-site clinical trial. The trial is a single-arm prospective, interventional clinical study. Results will be analyzed to determine the safety and efficacy of commercially approved catheters for the achievement of acute hemostasis without the need for cauterization.

Eligibility criteria: Inclusion Criteria:

* Male age from 40 through 85 years with LUTS due to BPH

Exclusion Criteria:

* Any severe illness that would prevent complete study participation or confound study results

Primary outcomes:
measure: Completion of the intended surgical procedure
timeFrame: 7 days post-op
measure: Proportion of subjects that require electrocautery or any other intervention post catheter removal.
timeFrame: 7 days post-op
Secondary outcomes:
Other outcomes:
Locations:
city: Nadiad
country: India
facility: Muljibhai Patel Urological Hospital
state: Gujarat
Study officials:
affiliation: Muljibhai Patel Urological Hospital
name: Ravindra Sabnis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00390663: A Prospective Randomised Controlled Trial of Management of Recurrent Nosebleeds in Children
Official title: A Prospective Randomised Controlled Trial of Management of Recurrent Nosebleeds in Children: Antiseptic Cream Alone v's Antiseptic Cream With Nasal Cautery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Epistaxis
Keywords: Paediatric
Epistaxis
Nose bleed
Naseptin
Lead sponsor: NHS Greater Glasgow Yorkhill Division
Sponsor class: OTHER
First posted: 2006-10-20
Enrollment: 216
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine whether the selective application of a combined treatment regimen of silver nitrate cautery and 4 weeks of Naseptin cream is superior to naseptin treatment alone in the management of recurrent paediatric epistaxis.


Eligibility criteria: Inclusion Criteria:

* Children aged 1 - 14
* History of repeated epistaxis with at least 1 episode in the previous 4 weeks prior to attending the ENT clinic.
* Presence of prominent vessels on the anterior nasal septum on the side that reportedly bleeds (or on at least one side if bleeding is reported to be bilateral)

Exclusion Criteria:

* No prominent vessels on examination (these children will be randomised but will be prescribed Naseptin alone and followed up in the same way as the children in the trial, for completeness of data)
* Known bleeding disorders.
* Allergy to peanuts, neomycin or chlorhexidine
* Other causes of nose bleeding eg tumour.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Royal Hospital for Sick Children
state: Strathclyde
Study officials:
affiliation: Royal Hospital for Sick Children
name: Haytham Kubba, MBBS(Hons) MPhil FRCS FRCSEd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04830163: Brain State-dependent PCMS in Chronic Stroke
Official title: Upregulating Corticospinal Function After Stroke Using Brain State-dependent Paired Corticomotoneuronal Stimulation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Stroke
Keywords: chronic, movement
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2021-04-02
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: After stroke, people often have difficulty using their hands. Combined brain and nerve stimulation can strengthen the neural pathways that control hand function. In this study, we will deliver combined brain and nerve stimulation during specific time windows that increase activation of neural pathways underlying hand function. We will compare the effects of combined brain and nerve stimulation during these optimal time windows to the effects of combined brain and nerve stimulation applied during random time windows on post-stroke hand function.


Eligibility criteria: Inclusion Criteria:

* History of stroke \> 6 months ago
* Presence of residual upper extremity hemiparesis
* Willingness to participate
* Ability to provide informed consent
* Upper extremity Fugl-Meyer score \< 66
* Mini Mental State Exam score \> 24
* Discernible and reliable motor-evoked potential (MEP) elicited following single-pulse TMS to the lesioned hemisphere

Exclusion Criteria:

* History of neurological disease other than stroke
* Presence of contraindications to transcranial magnetic stimulation (TMS) or peripheral nerve stimulation (PNS), including: history of adverse reactions to TMS or PNS metal in head, eyes, neck, chest/trunk, or arms, including but not limited to shrapnel, surgical clips, fragments from metalworking, fragments from welding, implanted device, history of frequent and severe headaches or migraines, immediate family history of seizure or epilepsy, personal history of seizure or epilepsy, current, suspected, or planned pregnancy, current or recent (within the last 3 months) use of medications acting on the central nervous system other than selective serotonin reuptake inhibitors (SSRIs), including but not limited to antipsychotic drugs, benzodiazepines, prescription stimulants.
* Upper extremity Fugl-Meyer score ≥ 66 (66 is the maximum on this scale)
* Mini Mental State Exam score \<= 24
* No discernible and reliable MEP elicited following single-pulse TMS to the lesioned hemisphere

Primary outcomes:
measure: Maximum hand force output
timeFrame: up to 1 hour after intervention
measure: Maximum hand muscle activation
timeFrame: up to 1 hour after intervention
Secondary outcomes:
measure: Amplitude of motor evoked potentials
timeFrame: up to 1 hour after intervention
measure: Time to complete the 9-hole peg test
timeFrame: up to 1 hour after intervention
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
Study officials:
References:
Clinical trial NCT00248963: Study Evaluating Levonorgestrel and Ethinyl Estradiol in Oral Contraception
Official title: A Multicenter, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Levonorgestrel 90 Mg and Ethinyl Estradiol 20 Mg in a Continuous 28-Day Regimen for Oral Contraception Versus a Cyclic 21-Day Regimen Oral Contraceptive
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Oral Contraceptive
Keywords: Oral Contraceptive
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-11-04
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: ECT

Brief summary: To evaluate the contraceptive efficacy of an oral contraceptive containing a combination of LNG 90 mg/EE 20 mg in a continuous-use regimen and to evaluate the safety compared to LNG 100 mg/EE 20 mg for 21 days followed by a 7-day hormone-free interval in a cyclic regimen.


Eligibility criteria: Inclusion Criteria:

* Healthy women aged 18 to 49 years who are willing to rely upon a combination birth control pill as their only method of contraception.
* Women must be sexually active and at risk for becoming pregnant.
* Women must have had regular (21- to 35- day) menstrual cycles for the 3-month period preceding study visit 1.

Exclusion Criteria:

* High blood pressure
* Age greater then 34 and smoking more than 15 cigarettes per day.
* Depression requiring hospitalization or associated with suicidal ideation within the last 3 years.

Primary outcomes:
measure: To evaluate the contraceptive efficacy of an OC containing a combination of LNG 90 mg/EE 20 mg in a continuous-use regimen and the safety compared to LNG 100 mg/EE 20 mg for 21 days followed by a 7-day hormone-free interval in a cyclic regimen
Secondary outcomes:
measure: To evaluate the effects on vaginal bleeding profile, hemostatic balance, lipid, carbohydrate, bone metabolism measures, hemoglobin levels, discontinuation rates, compliance with respect to pill taking, subject satisfaction
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05382663: The Jordan Study for End-Stage Renal Disease Subjects
Official title: Non-Invasive Monitoring of End-Stage Renal Disease Subjects Using Alio Medical Remote Monitoring System (RMS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: End Stage Renal Disease
Lead sponsor: Alio, Inc.
Sponsor class: INDUSTRY
First posted: 2022-05-19
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: To compare the Alio device to blood draws.

Detailed description: Eligible subjects who have signed a consent form will be asked to wear the Alio device at specified location(s) for up to four regularly scheduled dialysis sessions. The device will be placed and worn throughout the entire session.

Subjects will have blood draws that will be used to compare to device metrics. Additional vitals and monitoring may happen throughout this study.

Eligibility criteria: Inclusion Criteria:

* 18 and older
* maintenance dialysis for ESRD via AVF/AVG in an arm location for at least 6 months
* written informed consent
* able to wear the SmartPatch as instructed and follow study protocols

Exclusion Criteria:

* Skin near the proximity of Patch placement is swollen, infected and/or inflamed
* pregnancy
* serious medical condition which in the opinion of the investigator may adversely affect the safety of the subject or the device being evaluated
* AVF/AVG in a non-arm location
* participants with novel indications for their AVG (ie. HeRO grafts)
* participation in any other clinical trials that could affect the quality of study data

Primary outcomes:
measure: 1.Alio Device comparison to Hct via blood draw
timeFrame: through study completion, an average of 1 year
measure: 1.Alio Device comparison to K+ via blood draw
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Jordan Center for Pharmaceutical Research
Study officials:
affiliation: Alkhansaa Hospital
name: Tawfiq Arafat, MD
role: PRINCIPAL_INVESTIGATOR
References: