louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05742581: Critical Shoulder Angle and Acromial Index on 3D Models
Official title: Evaluation of the Relationship Between Critical Shoulder Angle and Acromial Index Measurements With Rotator Cuff Rupture on 3D Models
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shoulder Injuries
Rotator Cuff Tears
Rotator Cuff Injuries
Lead sponsor: Yuksek Ihtisas University
Sponsor class: OTHER
First posted: 2023-02-24
Enrollment: 44
Sex: ALL
Minimum age (years): 17
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In this study, computed tomography examinations of patients who applied to Gazi University Faculty of Medicine Department of Orthopedics and Traumatology between 2016-2019 were examined retrospectively.

Brief summary: Objective: The relationship between rotator cuff tears and morphological features of the shoulder joint has not been fully explained. The earlier studies are usually done with two-dimensional radiography images, but joint positions and bone formations could not be fully evaluated in two-dimensional images. This study aims to evaluate the relationship between rotator cuff tears and critical shoulder angle (CSA) and acromial index (AI) values in three dimensions.

Methods: This study examined computerized tomography of 24 rotator cuff tears (rotator cuff tear group) and 20 Bankart lesions, and no rotator cuff tears (control group). CSA and AI were measured on three-dimensional glenohumeral joint models obtained by three-dimensional reconstructions of computed tomography examinations.

The investigators anticipate results of this study will guide clinicians in revealing the etiology of rotator cuff degeneration and determining the surgical method to be used for treatment.


Eligibility criteria: Inclusion Criteria:

* A total of 44 patients, including 24 patients with proven rotator cuff tear by arthroscopic surgery (rotator cuff tear group) and 20 patients with proven Bankart lesion and no rotator cuff tear by arthroscopic surgery (control group), were included in the study.

Exclusion Criteria:

* Those with an inflammatory disease and trauma history were not included in the study.

Primary outcomes:
measure: Critical Shoulder Angle
timeFrame: 2 hours
measure: Acromial Index
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Yuksek Ihtisas University
state: Çankaya
Study officials:
References:
citation: Watanabe A, Ono Q, Nishigami T, Hirooka T, Machida H. Association between the Critical Shoulder Angle and Rotator Cuff Tears in Japan. Acta Med Okayama. 2018 Dec;72(6):547-551. doi: 10.18926/AMO/56371.
Clinical trial NCT01230281: A Study to Evaluate Pharmacokinetics of C3G and to Estimate Antioxidative Markers After Repeated Administration of Black Bean Seed Coat Extract
Official title: A Study to Evaluate Pharmacokinetics of C3G and to Estimate Antioxidative Markers After Repeated Administration of Black Bean Seed Coat Extract
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxidative Stress
Keywords: C3G
Oxidative stress
Antioxidant
Black bean
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
Collaborators: name: Rural Development Administration, Korea
First posted: 2010-10-29
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This study is to evaluate pharmacokinetic-pharmacodynamic property of C3G after administration of Mulberry fruit extract to 12 healthy Korean volunteers. Plasma concentration of C3G and the antioxidative markers such as total antioxidative capacity and attack of free oxygen radical will be measured.

Additional objective is to investigate the multiple dose (2 weeks) safety of daily 1000mg black bean seed coat extract.

This study, as an exploratory trial, does not required statistical hypothesis


Eligibility criteria: Inclusion Criteria:

* Body weight \>55 kg for male, \>45 kg for female (within 80-120% of Ideal body weight)
* Give written informed consent and voluntarily decide participation

Exclusion Criteria:

* Acute or chronic disease symptom on screening
* Existing active and clinically significant disease involving more than one organ system
* Known allergy to Mulberry or other berries
* Positive drug or alcohol screening
* Smokers of 10 or more cigarettes per day
* Participation in a clinical trial during last 2 month prior to the start of the study
* Pregnancy

Primary outcomes:
measure: Cmax - Maximum Observed Concentration - C3G in Plasma
timeFrame: Blood samples collected over 6 hours
measure: AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - C3G in Plasma
timeFrame: Blood samples collected over 6 hours
measure: Antioxidative markers
timeFrame: 2 weeks
Secondary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: for 4 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St.Mary's Hospital
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Dong-Seok Yim, M.D., PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04515381: Title: Effect of Therapeutic Touch on Daytime Sleepiness, Stress and Fatigue
Official title: Mardin Artuklu University Of Scientific Research Projects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Fatigue
Sleepiness
Keywords: Therapeutic touch
Daytime sleepiness
Sleep quality
Stress
Fatigue
Nurse-midwifery student
Lead sponsor: Mardin Artuklu University
Sponsor class: OTHER
First posted: 2020-08-17
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Objective: This study was conducted to assess the effect of therapeutic touch on stress, daytime sleepiness, sleep quality and fatigue among the students of nursing and midwifery.

Design: Randomized placebo-controlled study.

Detailed description: The trial was conducted between April and July 2018. The students who met the inclusion criteria were separated into three groups through randomization method as in therapeutic touch (n=32), placebo (n=32) and control (n=32), and a total of 96 students participated in the study. In this randomized placebo controlled study, the therapeutic touch group were subjected to therapeutic touch for twice a week throughout 4 weeks with each session of 20 minutes. The data was acquired via Student Information Form, Epworth Sleepiness Scale, Pittburgh Sleep Quality Index, Perceived Stress Scale and Visual Analogue Scale for Fatigue.

Eligibility criteria: Inclusion Criteria:

* students who were at and above the age of 18,
* were the 1st year, 2nd year, 3rd year or 4th year students of nursing or midwifery,
* did not receive any energy therapy (Reiki, healing touch, therapeutic touch),
* received a score above 10 from the Epworth sleepiness scale (ESS),
* did not have any communication problem,
* and accepted to take part in the study were included in the study.

Exclusion Criteria:

* Students who were getting a psychologic and/or pharmacologic treatment in regard to their sleep, fatigue and stress problems,
* previously got a psychiatric diagnosis, still had a psychiatric illness,
* previously or still used anxiety (psychotropic) medicines were excluded from the study.

Primary outcomes:
measure: Change in Perceived Stress Scale
timeFrame: Change from baseline and 4 weeks.
measure: Change in Epworth Sleepiness Scale
timeFrame: Change from baseline and 4 weeks.
measure: Change in Pittsburgh Sleep Quality Index
timeFrame: Change from baseline and 4 weeks.
measure: Change in Visual Analogue Scale
timeFrame: Change from baseline and 4 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Mardin
country: Turkey
facility: Mardin Artuklu University
Study officials:
References:
Clinical trial NCT00779181: A Dose-Ranging Study of the Safety and Efficacy of ADX415 in the Treatment of Essential Hypertension
Official title: A Phase 2, Dose-Ranging Study of the Safety and Efficacy of ADX415 Immediate-Release in the Treatment of Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Keywords: Hypertension
High blood pressure
Htn
Addrenex
Lead sponsor: Addrenex Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2008-10-24
Enrollment: 80
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: TREATMENT

Brief summary: The purpose of this study is to determine a safe and effective dose of ADX415 for the treatment of hypertension.


Eligibility criteria: Inclusion Criteria:

* Mild to moderate hypertension
* Age 18-75 years, inclusive

Exclusion Criteria:

* Clinically significant illnesses or abnormalities upon evaluation
* Current treatment with 3 or more antihypertensive meds
* Presence of Type I or uncontrolled Type II diabetes
* Presence of alcohol or drug abuse

Primary outcomes:
measure: Change in ABPM measures
timeFrame: Baseline to Day 26
Secondary outcomes:
measure: Treatment emergent adverse events, lab tests, vitals signs, and ECGs
timeFrame: Throughout treatment period
Other outcomes:
Locations:
city: Austin
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Addrenex Pharmaceuticals, Inc.
name: Moise Khayrallah, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06659081: Effect of Subepithelial Connective Tissue Graft with Socket Shield Technique
Official title: Effect of Subepithelial Connective Tissue Graft with Socket Shield Technique on Periimplant Tissues in Immediate Implant Procedure
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Socket Shield Technique Implant Placement
Immediate Implant Placement
Keywords: partial extraction therapy
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-10-26
Enrollment: 14
Sex: ALL
Minimum age (years): 21
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to Evaluate of the soft tissue profile changes and labial plate of bone in the anterior esthetic area when using socket shield technique in conjunction with immediate implant and subepithelial connective tissue graft, in comparison to using immediate implant combined by subepithelial connective tissue graft. The main questions it aims to answer is :

* does the socket shield technique better preserve gingival contours and connective tissues, resulting in improved esthetic outcomes?
* Researchers will compare socket shield combined with immediate implant placement and a subepithelial connective tissue graft to immediate implant placement with just a subepithelial connective tissue graft to see if more favorable soft tissue profile changes and better preservation of the labial plate of bone are obtained.

participants will :

. subjected to partially extracted socket with immediately placed implant and subepithelial connective tissue graft.

.subjected to immediate implant with subepithelial connective tissue graft.


Eligibility criteria: Inclusion Criteria:

* Medically free
* Maxillary esthetic zone extended to the second premolar with healthy roots
* Good oral hygiene
* Hopeless teeth

Exclusion Criteria:

* Patients with systemic conditions that can affect bone turnover
* Smokers
* Pregnant women
* Chronic and active periodontal disease
* Vertical and horizontal root fracture
* Dehiscence or fenestration of the labial plate of bone
* Gingival recession

Primary outcomes:
measure: Assessment of soft tissue profile around the implant
timeFrame: change from baseline at six months
Secondary outcomes:
measure: Assessment of labial plate of bone around the implant
timeFrame: change from baseline at six months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of dentistry -Ain shams university
Study officials:
affiliation: faculty of dentistry- Ain shams university
name: Hala A. Abo el ela, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00967395: Effect of Healing on Rheumatoid Arthritis
Official title: Effect of Healing on Rheumatoid Arthritis: a Three-arm Double-blind, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Lead sponsor: Frederiksberg University Hospital
Sponsor class: OTHER
Collaborators: name: The IMK Foundation
name: The Danish Rheumatism Association
name: Oak Foundation
First posted: 2009-08-27
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The hypothesis is that healing may influence the patient's general status by altering psychological as well as other body functions of importance for the rheumatoid arthritis. This is tested in a three group design with a control group and two groups receiving healing with or without a healer present. The study is randomized and double blind.

Detailed description: The central claim of healers is that this process facilitates self-healing in the patient. Spiritual healing includes several categories, including 'therapeutic touch' and 'intercessory prayer', and the healing may be attributed to God, spirits, universal forces or energies, biological healing energies residing in the healer, or self-healing powers or energies thought to reside latent in the healed organism. The highly controversial hypothesized effects of distant or spiritual healing contradict our traditional sense of reality and are in conflict with what is generally viewed as being in correspondence with modern science.

Eligibility criteria: Inclusion Criteria:

* Patients with rheumatoid arthritis in a stable medication the past 3 months written informed consent

Exclusion Criteria:

* Not able to arrange own transport, language problems

Primary outcomes:
measure: DAS28
timeFrame: 8 weeks follow-up
Secondary outcomes:
measure: Colour Doppler fraction
timeFrame: 8 weeks follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Frederiksberg University Hospital
name: Bente Danneskiold-Samsøe, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03794895: Prediction of Response to IUCD Associated Menorrhagia Using Doppler
Official title: Assessment of Efficacy of Uterine Artery Doppler in Predicting the Response to Mefenamic Acid During Treatment of Women With IUCD Associated Menorrhagia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Women's Health: Amenorrhea/Dysmenorrhea
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-01-07
Enrollment: 156
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Studying the efficacy of uterine artery doppler in predicting response to mefenamic acid in women having IUCD associated menorrhagia


Eligibility criteria: Inclusion Criteria:

* women in chile bearing period (age 20-35 yrs ) with history of regular menstrual cycle presenting with recent onset of more then three months menorrhagia after IUCD "copper T 380 A" insertion

Exclusion Criteria:

* history of bleeding tendency
* history of abnormal uterine bleeding due to other causes
* history of active liver disease
* history of antiplatelet or anticoagulant intake in the last month
* history of thyroid disease
* history of endometritis
* history of allergy to NSAIDs
* Adenomyosis
* women having contraindications to use NSAIDs e.g. peptic ulcer
* Insulin dependant diabetes mellitus

Primary outcomes:
measure: Resistance index and Pulsitality index (Predicting the response to IUCD associated menorrhagia)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AinshamsU
state: Abbaseya
Study officials:
affiliation: Ain Shams University
name: Yasmine Es Ismail, Bachelor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01821495: Study of DC-CIK to Treat NPC
Official title: A Randomized Controlled Study of Dendritic and Cytokine-induced Killer Cells (DC-CIK) Treatment in Patients With Staging Ⅱ-Ⅲ of Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Keywords: NPC,DC-CIK
Lead sponsor: Guangxi Medical University
Sponsor class: OTHER
First posted: 2013-04-01
Enrollment: 100
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: Concurrent of radiotherapy and chemotherapy is the main treatment method for patients with nasopharyngeal carcinoma (NPC). However, Relapse remains the major cause of treatment failure. A series of studies reported that dendritic and cytokine-induced killer cells (DC-CIK) have a broad anti-tumor spectrum. We suppose that DC-CIK will improve the prognosis of NPC. In this study, the patients with NPC will be treated with DC-CIK cells after concurrent of chemotherapy and radiotherapy. The purpose of this study is to evaluate the efficacy of DC-CIK for NPC.

Detailed description: About 60 patients with staging Ⅱ-Ⅲ of NPC, after accepting concurrent radiotherapy and chemotherapy, will be randomly divided into group A (receive DC-CIK treatment) or group B (just regularly follow up), and the randomize ratio will be 1:1. Patients in group A will receive 2-3 cycles of DC-CIK cells treatment (every 4 weeks). Patients in group B will have no anti-tumor therapy.

Eligibility criteria: Inclusion Criteria:

1. Patients with staging Ⅱ-Ⅲ of NPC;
2. Patients who had completed concurrent of radiotherapy and chemotherapy;
3. Patients who have a life expectancy of at least 12 weeks;
4. Eastern Cooperative Oncology Group (ECOG) performance status was 0-1;
5. The bone marrow functioned normally (WBC \> 4.0×109/L, Hb \> 120 g/L, PLT \> 100×109/L);
6. The ECG results were normal, and the liver and kidney were functional.

Exclusion Criteria:

1. Patients who had distant metastases by imaging studies;
2. Patients with uncontrolled infection; underlying disease that was severe or life-threatening;
3. Patients who were pregnant or lactating;
4. ECOG perform status ≥ 2;
5. Patients who are suffering from auto immune diseases or patients who need to accept glucocorticoid treatment.

Primary outcomes:
measure: progression-free survival(PFS)
timeFrame: 1 month
Secondary outcomes:
measure: overall survival(OS)
timeFrame: 1 month
Other outcomes:
measure: Laboratory findings
timeFrame: 1 month
Locations:
city: Nanning
country: China
facility: Guangxi Medical University
state: Guangxi
Study officials:
affiliation: Guangxi Medical University
name: Hanfeng Liu
role: STUDY_CHAIR
References:
Clinical trial NCT00842595: Efficacy , Safety of Treatment R NIMP for Relapsed Aggressive Lymphomas
Official title: Phase II Study of Treatment of Relapsed Agressive Lymphomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diffuse Large B-Cell Lymphoma
Keywords: relapsed aggressive B-cell lymphoma
Chemotherapy
Lead sponsor: French Innovative Leukemia Organisation
Sponsor class: OTHER
First posted: 2009-02-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of the protocol is to estimate the complete response rate of three courses of the association of rituximab, navelbine, ifosfamide, mitoxantrone, and prednisone in relapsed aggressive non hodgkin's B-cell lymphoma

Detailed description: Phase II study of the efficacy and toxicity of rituximab, navelbine, ifosfamide, mitoxantrone, and prednisone in relapsed aggressive non hodgkin's B-cell lymphoma.

The study intervention is an administration of 3 courses of the abovementioned drugs, witch doses are detailed below. Remission is assessed and the investigator is free to proceed with any kind of consolidation , he decides best for the patient( high dose or standard chemotherapy).

The addition of Rituximab the the NIMP protocol is warranted on the basis of previous publications wtich have shown a significant advantage in addition to chemotherapy in complete remission rate and in overall survival.

Navelbine has shown an interesting activity in lymphoma relapse. Mitoxantrone has a good toxicity profile for patients who have prevously received anthracyclines, and there is not so much cross resistance between the two drugs.

Ifosfamide is commonly used in the treatment of relapsed and refractory lymphoma, because of its low hematologic toxicity profile and good antitumor activity.

Eligibility criteria: Inclusion Criteria:

* Both genders, between 18 and 75 years old
* CD 20+ large cell lymphoma
* In first relapse
* No previous autologous stem cell transplantation or relapsing more than 12 months after an autologous stem cell transplantation
* Ann Arbor stage I, II, III ou IV
* ECOG 0,1 or 2
* Signed informed consent

Exclusion Criteria:

* age: before 18 and more than 75 years old
* other type of lymphoma
* Informed consent not signed

Primary outcomes:
measure: Complete remission rate
timeFrame: CR AFTER 3 R NIMP COURSES
Secondary outcomes:
measure: overall remission rate
timeFrame: OS after 3 R NIMP COURSES
measure: Toxicity
timeFrame: R NIMP TOLERANCE
measure: Pharmacoeconomy
timeFrame: treatment phramacoeconomy
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital COCHIN
Study officials:
affiliation: French Innovative Leukemia Organisation
name: Emmanuel GYAN
role: PRINCIPAL_INVESTIGATOR
References: