louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00369148: Combination of Glinides With Premixed Insulin
Official title: Evaluation of Usefulness of Combination Therapy of Rapid Acting Insulin Secretagogue (Glinide) With Premixed Insulin in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabets Mellitus
Keywords: glinides
premixed insulin
combination therapy
glycemic control
Lead sponsor: Keio University
Sponsor class: OTHER
First posted: 2006-08-29
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Combination therapy of glinides with premixed insulin provides better glycemic control than premixed insulin alone.

Detailed description: Type 2 diabetic patients undergoing twice daily injections of premixed insulin are administered glinides (10mg of mitiglinide or 90 mg of nateglinide) at lunchtime without changing their insulin regimen. Twelve weeks after administration of the glinides, they are discontinued. HbA1c levels at the start of glinide administration, 12 weeks after administration, and 12 weeks after discontinuation are measured.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of type 2 diabetes
* Who undergoes twice daily injection of premixed insulin
* Whose HbA1c is more than 6.5% and less than 8.0%

Exclusion Criteria:

* Whose change of HbA1c is more than 1.0% during 12 weeks observational period

Primary outcomes:
measure: glycohemoglobin
Secondary outcomes:
measure: anhydroglucitol
measure: lipid profile
measure: body weight
measure: blood pressure
Other outcomes:
Locations:
city: Kawasaki
country: Japan
facility: Nippon Kokan Hospital
state: Kanagawa
city: Hamamatsu
country: Japan
facility: Hamamatsu Red Cross Hospital
state: Shizuoka
city: Minato-ku
country: Japan
facility: Saiseikai Central Hospital
state: Tokyo
city: Minato-ku
country: Japan
facility: Kitasato Institute Hospital
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Keio University Hospital
state: Tokyo
city: Toshima-ku
country: Japan
facility: Tokyo Metropolitan Ohtsuka Hospital
state: Tokyo
Study officials:
affiliation: Keio University
name: Akira Shimada, MD, PhD
role: STUDY_CHAIR
affiliation: Saiseikai Central Hospital
name: Yoshihito Atsumi, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00109148: An Investigational Drug Study in Obese (Considerably Overweight) Patients (0364-006)
Official title: A Study to Assess the Safety and Efficacy of MK0364 in Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Keywords: Obesity and obesity-related medical conditions
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-04-25
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and effectiveness of an investigational drug in patients with obesity (considerably overweight).


Eligibility criteria: Inclusion Criteria:

* Patients who are obese (considerably overweight) based on body mass index.

Exclusion Criteria:

* Patients with serious or unstable current or past medical conditions

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Addy C, Wright H, Van Laere K, Gantz I, Erondu N, Musser BJ, Lu K, Yuan J, Sanabria-Bohorquez SM, Stoch A, Stevens C, Fong TM, De Lepeleire I, Cilissen C, Cote J, Rosko K, Gendrano IN 3rd, Nguyen AM, Gumbiner B, Rothenberg P, de Hoon J, Bormans G, Depre M, Eng WS, Ravussin E, Klein S, Blundell J, Herman GA, Burns HD, Hargreaves RJ, Wagner J, Gottesdiener K, Amatruda JM, Heymsfield SB. The acyclic CB1R inverse agonist taranabant mediates weight loss by increasing energy expenditure and decreasing caloric intake. Cell Metab. 2008 Jan;7(1):68-78. doi: 10.1016/j.cmet.2007.11.012.
Clinical trial NCT05238948: CKD-506 Drug-Drug Interaction Study in Healthy Male Subjects
Official title: A Phase 1, Open-label, 1-sequence Crossover Drug-drug-interaction Study to Assess the Effect of Single and Multiple Doses of CKD-506 on the Single-Dose Pharmacokinetics of Midazolam, A CYP3A4 Substrate, in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug Drug Interaction
Keywords: CYP3A4
Midazolam
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2022-02-14
Enrollment: 17
Sex: MALE
Minimum age (years): 20
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: One arm and 1-sequence crossover
Primary purpose: SUPPORTIVE_CARE

Brief summary: This will be a Phase 1, open-label, 1-sequence crossover drug-drug-interaction study in 16 healthy male subjects to assess the effect of single and multiple doses of CKD-506 on the single-dose PK of oral midazolam. Midazolam will be used as a cytochrome P450 (CYP)3A4 substrate in this study.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects
* Ability and willingness to abstain from methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, energy drinks)
* Ability and willingness to abstain from foods and beverages containing grapefruit, Seville oranges, pomelos, star fruit, or cranberries

Exclusion Criteria:

* History of relevant drug and/or food allergies.
* Using tobacco products
* Positive drug and alcohol screen

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax) of oral midazolam
timeFrame: For 24 hours
measure: Area Under Curve (AUC) of oral midazolam
timeFrame: For 24 hours
Secondary outcomes:
measure: Cmax of CKD-506 and its metabolites following oral single and multiple doses of CKD-506
timeFrame: For 24 hours
measure: AUC of CKD-506 and its metabolites following oral single and multiple doses of CKD-506
timeFrame: For 24 hours
measure: Time to Maximum Plasma Concentration (Tmax) of CKD-506 and its metabolites following oral single and multiple doses of CKD-506
timeFrame: For 24 hours
measure: Number of treatment emergent adverse events
timeFrame: Over 4 weeks
measure: Number of participants with treatment emergent adverse events
timeFrame: Over 4 weeks
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: PRA Health Sciences
Study officials:
affiliation: PRA Group BV, a PRA Health Sciences company
name: Maria Velinova,, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01678248: The Effectiveness of Intravitreal Avastin Injection for CRVO
Official title: The Effectiveness of Intravitreal Avastin Injection for CRVO
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Central Retinal Vein Occlusion
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2012-09-03
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients who suffer from CRVO and were injected by bevazicumab intravitrealy

Brief summary: to determine the effectivness of intravitreal avastin injection on visual acuity on people that suffer from central retinal vein occlusion


Eligibility criteria: Inclusion Criteria:

* patients above 18 years old
* suffer from CRVO
* maximal visual acuity 6/15

Exclusion Criteria:

* VA of LP
* retinal disease other than CRVO
* incomplete medical record
* follow up less than 6 months

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Safed
country: Israel
facility: Ziv Medical Center
Study officials:
References:
Clinical trial NCT02547948: CD19-targeting CAR T Cells for B Cell Lymphoma
Official title: CD19-targeting CAR T Cells for Refractory B Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: B Cell Lymphoma
Keywords: CD19
CAR T Cells
Lymphoma
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
First posted: 2015-09-14
Enrollment: 0
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: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of CD19-targeting CAR T Cells infusion for B Cell Lymphoma.

Detailed description: Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and efficacy in patients with B cell lymphoma or leukemia. The CAR consists of a CD19 targeting antibody scFv with two intracellular signaling domains derived from CD3 zeta and CD28. Autologous T cells will be gene-engineered with the CAR gene using a retrovirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.

Eligibility criteria: Inclusion Criteria:

1. Relapsed or refractory CD19+ B-cell lymphoma.
2. Measurable disease.
3. Performance status ECOG 0-2.
4. Age:18-80.
5. Fertile females/males must consent to use contraceptives during participation of the trial.
6. Signed informed consent

Exclusion Criteria:

1. Any significant medical or psychiatric illness that would prevent the patient from giving informed consent or from following the study procedures.
2. Patients with primary CNS lymphoma.
3. Known human immunodeficiency virus (HIV) infection.
4. Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection).
5. Other serious underlying medical conditions, which, in the Investigator's judgment, could impair the ability of the patient.
6. Treatment with an investigational product within 30 days prior to enrollment, or at least 5 half lives of that drug, which is longest.
7. Patients that do not consent to that tissue and blood samples are stored in a biobank.
8. Pregnancy.

Primary outcomes:
measure: CAR T cell persistence
timeFrame: up to 24 months
Secondary outcomes:
measure: Tumor load
timeFrame: up to 24 months
Other outcomes:
measure: B cell number and immunoglobulins
timeFrame: up to 24 months
Locations:
city: Guangzhou
country: China
facility: Central laboratory in Fuda cancer hospital
state: Guangdong
Study officials:
affiliation: Fuda Cancer Hospital
name: Lizhi Niu, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02467348: Incidence And Outcome Of Paracentesis Induced Circulatory Dysfunction In Acute-On-Chronic Liver Failure.
Official title: To Study the Incidence And Outcome Of Paracentesis Induced Circulatory Dysfunction In Acute-On-Chronic Liver Failure Undergoing Less Than 5 Litres Of Ascitic Fluid Tap With Or Without Albumin Infusion.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute on Chronic Liver Failure
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2015-06-10
Enrollment: 80
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: All consecutive patients admitted in ILBS from MAY 2015 to DECEMBER 2016.ACLF (Acute on chronic Liver Failure). ACLF will be randomize into

Group 1: MVP (Modest Volume Paracentesis) OF Less than 5 liters with IV albumin at a dose 8 gms/L of ascitic fluid

Group 2: MVP (Modest Volume Paracentesis) of Less than 5 liters without albumin


Eligibility criteria: Inclusion Criteria:

1. All patients with acute hepatic insult manifesting as jaundice (Sr. Bil. ≥ 5 mg/dL) and coagulopathy (INR≥1.5), complicated within 4 weeks by ascites and/or encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease (ACLF) admitted in the hospital.
2. All Cirrhotics decompensated with ascites admitted in the hospital.
3. Grade II/III ascites
4. Need for paracentesis.

Exclusion Criteria:

1. Age \<12 or \> 75 years
2. Hepatocellular carcinoma
3. Non cirrhotic ascites such as malignancy or tubercular peritonitis
4. Serum Cr \>1.5mg%
5. Refractory septic shock
6. Grade III/IV hepatic encephalopathy
7. Abdominal wall cellulitis
8. Active variceal bleed
9. Respiratory, cardiac and renal failure
10. Refusal to participate in the study

Primary outcomes:
measure: Total number of patients develop Circulatory Dysfunction because of paracentesis.
timeFrame: 1 Year
Secondary outcomes:
measure: Survival
timeFrame: 28 days
measure: Total number of patients develop hepatorenal Syndrome.
timeFrame: 1 Year
measure: Total number of patients develop hyponatremia.
timeFrame: 1 Year
measure: Changes in aldosterone with volume of ascitic fluid tap
timeFrame: 1 Year
measure: Changes in plasma renin activity
timeFrame: 1 year
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver and Biliary Sciences
state: Delhi
Study officials:
References:
citation: Arora V, Vijayaraghavan R, Maiwall R, Sahney A, Thomas SS, Ali R, Jain P, Kumar G, Sarin SK. Paracentesis-Induced Circulatory Dysfunction With Modest-Volume Paracentesis Is Partly Ameliorated by Albumin Infusion in Acute-on-Chronic Liver Failure. Hepatology. 2020 Sep;72(3):1043-1055. doi: 10.1002/hep.31071. Epub 2020 Jul 9.
Clinical trial NCT06268548: Effect of Manual Diaphragmatic Activation on Diaphragm Function in Patients With Gastroesophageal Reflux Disease
Official title: Effect of Manual Diaphragmatic Activation on Diaphragm Function in Patients With Gastroesophageal Reflux Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diaphragm Dysfunction
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was conducted to investigate Effect of manual diaphragmatic activation on diaphragm function in patients with gastroesophageal reflux disease

Detailed description: Thirty both gender patients with gastroesophageal reflux disease enrolled in this study , study group And control group. To investigate Effect of manual diaphragmatic activation on diaphragm function in patients with gastroesophageal reflux disease

Eligibility criteria: Inclusion Criteria:

* patients with gastroesophageal reflux disease.
* the age will be ranged from 20 to 50 .
* body mass index from 20 to 34,9 kg/m2 .
* low level of physical therapy

Exclusion Criteria:

* Pregnancy
* open wound
* abdominal or spinal surgery
* Congenital or acquired disorder

Primary outcomes:
measure: Diaphragm Excursion
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of physical therapy
Study officials:
References:
Clinical trial NCT06195748: Ankle Kinesio Taping on Balance and Functional Performance in Obese Females.
Official title: The Effect of Ankle Kinesio Taping on Balance and Functional Performance in Obese Female Collegiate Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Obesity is one of the most dangerous factors affecting the joints, which must be prevented due to arthritis and the long-lasting, tiring effects that affect a person's life \[1\], The most important of these are foot problems due to weight and excess pressure, It is also one of the factors that greatly affects walking movement because it increases the load on joint movement, This increases the risk of musculoskeletal diseases.

Detailed description: It had been reported that obese subjects have a higher prevalence of falls and ambulatory stumbling or a loss of balance than their non-obese counterparts. Excess weight increases the stress within the bones, joints, and soft tissues, resulting in impaired musculoskeletal function. such as abnormal mechanics of the body. These impairments, such as impaired balance, gait, strength, sensory function, and neuromuscular function have been identified as strong risk factors for falls.

Participants that are eligible to participate to the study will be distributed into two groups: Group A will receive ankle kinesiotaping on the dominant leg. While, Group B will receive placebo kinesiotaping on the dominant leg. The treatment duration will be 6 weeks for both groups.

Eligibility criteria: Inclusion Criteria:

* Female students between 18 and 25 years old
* BMI of 30 kg/ m2 or more

Exclusion Criteria:

* Orthopedic or neurosurgery injury past 6 months
* Ankle edema
* Skin allergy to the tape
* Abnormalities of the nervous system
* Any previous history of injury
* Use of medication in the past 3 months
* Regular physical activity at least three times a week

Primary outcomes:
measure: Static balance
timeFrame: 6 weeks
Secondary outcomes:
measure: Dynamic balance
timeFrame: 6 weeks
measure: Single leg hop test
timeFrame: 6 weeks
measure: Single leg vertical jump
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy
Study officials:
affiliation: Assisstant professor of physical therapy for surgery, Faculty of physical therapy
name: Hadaya M Eladl, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03988348: Perioperative Outcome of Infraumbilical Versus a Modified Intraumbilical Direct Trocar Insertion
Official title: Perioperative Outcome of Infraumbilical Versus a Modified Intraumbilical Direct Trocar Insertion in Gynecologic Laparoscopy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gynecologic Disease
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-06-17
Enrollment: 110
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Laparoscopic surgery is now a well-established alternative to open surgery for many gynecological disorders owing to its faster wound healing, shorter hospital stay, less postoperative pain, and better cosmetic results. Postoperative scar cosmoses is a critical issue for women, especially for young women. These scars may have negative impacts, such as psychological consequences. The symptoms associated with the wound, such as pain, tenderness, and itching, can be induced by the scars


Eligibility criteria: Inclusion Criteria:

* All women subjected to direct trocar application as a part of any gynecologic procedure performed

Exclusion Criteria:

* Verres needle insertion.
* Patients with previous abdominal surgery and scar,
* umbilical hernia,
* previous laparoscopy or previous umbilical surgery,
* burns in the umbilical region;
* who have hyperpigmented skins.

Primary outcomes:
measure: the mean difference in the duration of surgery
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
Study officials:
References:
Clinical trial NCT06475248: Influence of Osteopathic Intervention on Cervical Muscles in Tension Headaches in Women
Official title: Influence of Osteopathic Intervention on Cervical Muscles in Tension Headaches in Women: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Tension Headaches
Keywords: Tension headaches
Trapezius Stretching
sternocleidomastoid Stretching
Suboccipital Inhibition
Manual Therapy
Osteopathy
HIT-6
Lead sponsor: Escola Superior de Tecnologia da Saúde do Porto
Sponsor class: OTHER
First posted: 2024-06-26
Enrollment: 43
Sex: FEMALE
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: This study aims to understand whether there is any relationship between the intervention on the trapezius, sternocleidomastoid and suboccipital muscles in patients with chronic tension headaches.

Detailed description: It is expected to find an improvement in the symptoms and frequency of tension headaches.

In this study, the investigators intend to see the effects of trapezius and sternocleidomastoid "stretching techniques", and "suboccipital inhibition" on tension headaches. To collect data, volunteers were asked to fill out the Headache Impact Test (HIT-6).

Eligibility criteria: Inclusion Criteria:

* Tension headaches;
* Being over eighteen years of age;

Exclusion Criteria:

* Loss of mobility of cervical;
* Cervical and shoulder pain during episodes;
* Other headaches (migraine, cervicogenic headache...)
* Other interventions and/or pharmacological treatment a few days before the intervention;
* Epilepsy;
* Trauma.

Primary outcomes:
measure: Change in the intensity and frequency of pain after the three treatment sessions;
timeFrame: One month after the first intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Escola Superior da Saúde do Porto
Study officials:
affiliation: Escola Superior da Saúde do Porto
name: Natália MO Campelo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cumplido-Trasmonte C, Fernandez-Gonzalez P, Alguacil-Diego IM, Molina-Rueda F. Manual therapy in adults with tension-type headache: A systematic review. Neurologia (Engl Ed). 2021 Sep;36(7):537-547. doi: 10.1016/j.nrleng.2017.12.005. Epub 2020 Apr 7.
citation: Lebedeva ER, Kobzeva NR, Gilev DV, Olesen J. The quality of diagnosis and management of migraine and tension-type headache in three social groups in Russia. Cephalalgia. 2017 Mar;37(3):225-235. doi: 10.1177/0333102416642603. Epub 2016 Jul 11.
citation: Hartman, L. S. (2013). Handbook of osteopathic technique. Springer