louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06404658: Analgesic Efficacy of Genicular Nerve Block Versus (IPack Block ) in Patients Undergoing (ACL) Repair
Official title: Analgesic Efficacy of Genicular Nerve Block Versus Local Anaesthetic Infiltration Between Popliteal Artery and Capsule of the Knee (IPACK Block ) in Patients Undergoing Anterior Cruciate Ligament (ACL) Repair by Knee Arthroscopy . A Randomized Controlled Prospective Study .
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Operative Pain
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 120
Sex: ALL
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: One of the most common injuries to the knee is an anterior cruciate ligament (ACL) sprain or tear due to trauma ACL damage is crippling and often requires repair with an arthroscopic method, which is an outpatient surgery. Nevertheless, patients experience severe postoperative pain on the first day after the ACL reconstruction.Efficient postsurgery pain management is an important part of patient recovery that is also crucial for their satisfaction.

Detailed description: The optimum role of peripheral nerve blocks in ACL reconstruction continue to be debated as a component of multi-modal analgesia . As such ,an ideal block for ACLR would target sensation but not motor function,have minimal complication risk,and be easily reproducible The genicular nerves include branches from the femoral, common peroneal, saphenous, tibial, and obturator nerves which innervate the knee capsule . The superolateral, superomedial, and inferomedial On the other hand, the interspace between the Popliteal Artery and Capsule of the Knee (IPACK) block provides analgesia on the posterior knee joint, and the application of a genicular or IPACK block has been be associated with promising outcomes following the ACLR surgery

Eligibility criteria: Inclusion Criteria:

- Patient age from 18 to 45 years old Patient status ASA I - II Patient body mass index (BMI) \<40 kg/m2

Exclusion Criteria:

* -Patients were excluded if they refused consent.
* Patients who are Not cooperative.
* BMI \>40 kg/m2.
* Allergy to local anesthetics.
* Patients with anticoagulation or bleeding problems.
* Previous nerve dysfunction.
* Physical status ASA class IV.

Primary outcomes:
measure: VAS score
timeFrame: 48 hour
Secondary outcomes:
measure: Ambulatory score
timeFrame: Within 48 hour
measure: Time of first rescue analgesia
timeFrame: within 24 hour
measure: Total opioid consumption post operative
timeFrame: Within 24 hour
measure: Incidence of occurrence of systemic toxicity
timeFrame: Within 24 hour
measure: The length of hospital stay .
timeFrame: within one week
Other outcomes:
Locations:
city: Benisuef
country: Egypt
facility: Benisuef University Hospital
Study officials:
References:
Clinical trial NCT04171258: Clinical Trial to Compare the Safety and Efficacy of Botulax® Versus Botox® in Patients With Cervical Dystonia
Official title: A Multi-center, Double-blind, Randomized, Parallel, Active-controlled, Phase I Clinical Trial to Compare the Safety and Efficacy of Botulax® Versus Botox® in Patients With Cervical Dystonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cervical Dystonia
Lead sponsor: Hugel
Sponsor class: INDUSTRY
First posted: 2019-11-20
Enrollment: 38
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the efficacy and safety of Botulax® in treatment of cervical dystonia


Eligibility criteria: Inclusion Criteria:

1. Male or female of aged over 19 years
2. Subjects diagnosed with primary cervical dystonia

Exclusion Criteria:

1. Subjects who have administered botulinum toxin within 16 weeks at the time of baseline
2. Pregnant or nursing
3. Females or males who do not agree on proper contraceptive measure

Primary outcomes:
measure: rate of adverse event
timeFrame: 12 weeks (during the clinical trial)
measure: Change From Baseline in the Total Score of the TWSTRS score.
timeFrame: Baseline to Week 4 , Week 8, Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hugel
Study officials:
References:
Clinical trial NCT02244658: Recombinant Human Thrombopoietin (rhTPO) in Management of Chemotherapy-induced Thrombocytopenia in Acute Myelocytic Leukemia
Official title: Recombinant Human Thrombopoietin (rhTPO) in Management of Chemotherapy-induced Thrombocytopenia in Acute Myelocytic Leukemia: a Multicenter Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Antineoplastic Adverse Reaction
Thrombocytopenia
Acute Myelocytic Leukemia
Keywords: chemotherapy-induced thrombocytopenia
recombinant human thrombopoietin
acute myelocytic leukemia
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2014-09-19
Enrollment: 80
Sex: ALL
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chemotherapy-related myelosuppression usually occurs in AML patients, which induces severe thrombocytopenia and haemorrhage, a leading cause of death. This clinical trial aims at evaluating efficacy and safety of rhTPO in management of chemotherapy-induced thrombocytopenia in acute myelocytic leukemia.

Detailed description: The investigators are undertaking a parallel group, multicentre, randomized controlled trial of 80 adults with chemotherapy-induced thrombocytopenia from 8 medical centers in China. AML patients with PLT count \<30×10\^9/L during the previous cycle of chemotherapy are randomized into two groups that one receives rhTPO at 1.0μg/kg·d subcutaneously for 7\~14 consecutive days and the other receives no rhTPO or other thrombopoietic factor. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.

Eligibility criteria: Inclusion Criteria:

* AML patients with PLT count \<30×10\^9/L during the previous cycle of chemotherapy to minimize the risk of clinically significant bleeding.

Exclusion Criteria:

* allergic history to biological agents; history of thrombotic or hemorrhagic diseases; M3 or M7 subtype; pregnancy; hypertension; cardiovascular disease; diabetes; liver and kidney function impairment;

Primary outcomes:
measure: Evaluation of platelet response
timeFrame: 21 days since the first administration
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu hospital, Shandong University
state: Shandong
Study officials:
References:
Clinical trial NCT01592058: Weight Change Among Users of Three Progestin-Only Methods of Contraception Over a 12-Month Time Period
Official title: Weight Change Among Users of Three Progestin-Only Methods of Contraception Over a 12-Month Time Period
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Weight Change
Keywords: weight change
contraception
birth control
progestin
progestin only
weight gain
depo
Depo Provera
DMPA
IUD
IUC
Mirena
Paragard
Implanon
implant
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2012-05-04
Enrollment: 427
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants already enrolled in the Contraceptive CHOICE Project will be offered participation during their 12-month follow up window if they had originally selected one of the four methods being studied during CHOICE enrollment.

Brief summary: The purpose of this study is to learn whether women who use progestin-only methods of birth control such as the contraceptive implant (Implanon), the levonorgestral-releasing IUS (Mirena), or depot medroxyprogesterone acetate(DMPA) will experience weight change compared to women using the non-hormonal copper IUC (ParaGard).

The investigators primary hypothesis is that users of DMPA will gain excess weight and increase their BMI above the copper-IUC users; secondarily, the investigators will compare users' data in the LNG-IUC and ENG implant groups to the copper-IUC group.


Eligibility criteria: Inclusion Criteria:

* Patients enrolled in CHOICE between the ages of 18 and 45 who consented to future studies
* Chose levonorgestrel-releasing IUD, copper IUD, the implant, or DMPA as their CHOICE baseline method
* Has baseline height and weight data collected from the on-campus enrollment site
* Able to come back to the on-campus enrollment site for consent process and enrollment activities

Exclusion Criteria:

* Recent history of DMPA use before starting their baseline CHOICE method
* Used current method for less than 11 months or more than 12 months and three weeks

Primary outcomes:
measure: Weight
timeFrame: Baseline and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Tessa E Madden, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03470558: Role of Dietary Habits in Efficacy of Bariatric Surgery - Study A
Official title: Role of Dietary Habits in Efficacy of Bariatric Surgery - Study A
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bariatric Surgery
Sleeve Gastrectomy
Obesity
Keywords: Diet
Dietary Habits
Weight changes
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-03-20
Enrollment: 400
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients electing to undergo sleeve gastrectomy.

Brief summary: The purpose of the study is to evaluate how dietary habits in the post-surgical year impact outcomes of bariatric surgery.

Detailed description: The obesity epidemic is a major public health concern with a significant economic burden in the USA. Bariatric surgery is the most effective and durable weight loss treatment, with long-term cardiometabolic health benefits. Among different types of bariatric procedures, sleeve gastrectomy (SG) has become the most commonly performed in USA. While SG is expected to result in a 50-60% excess weight loss, inter-individual differences in weight loss are large and approximately 25% of patients can be considered poor weight-loss responders who either do not lose a substantial amount of weight or regain the lost weight afterwards. The mechanisms underlying this clinical variation remain unknown and interventions to improve on these outcomes critically lacking. Of interest, altered daily dietary habits are experienced by a substantial proportion of bariatric surgery candidates, raising the question whether such alterations may contribute to inter-individual differences in weight loss success. Therefore, the purpose of this study is to evaluate how dietary habits in the post-surgical year impact outcomes of bariatric surgery.

Eligibility criteria: Inclusion Criteria:

* Bariatric surgery (sleeve gastrectomy) patients

Exclusion Criteria:

* Prior bariatric surgical procedures

Primary outcomes:
measure: Change in BMI at 1-year post-surgical
timeFrame: Baseline and one year
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Frank Scheer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: Ali Tavakkoli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05970458: Stoma Related Complications and Quality of Life Assessments Ethiopia and Sweden
Official title: Stoma Related Complications and Quality of Life Assessment: a Cross-sectional Study With Patients From Ethiopia and Sweden
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stoma Colostomy
Stoma Ileostomy
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (≥ 18 years old) with ileostomy or colostomy for more than two months, with willingness and ability to give informed consent

Brief summary: Cross-sectional comparative study of general and stoma-specific quality of life in patients with stoma in Addis Abeba, Ethiopia, and Stockholm, Sweden.

Detailed description: Objective: To evaluate the quality of life for patients with ostomy in Ethiopia and Sweden using a general and a specific assessment tool.

Design: Comparative descriptive cross-sectional study. Setting: Tikur Anbessa Specialized Hospital (TASH), Addis Abeba and South General Hospital, Stockholm.

Participants/Exposure: Patients with a permanent ostomy visiting the stoma center in Addis Abeba, patients waiting for ostomy reversal at TASH, and patients visiting the stoma clinic at South General Hospital.

Main outcomes and measure: Quality of life and stoma specific quality of life: EQ5D-5L and Stoma QoL.

Eligibility criteria: Inclusion Criteria:

* adult patients (≥ 18 years old)
* having an ostomy for more than two months
* willingness and ability to give informed consent

Exclusion Criteria:

* non-intestinal stoma

Primary outcomes:
measure: General quality of life
timeFrame: October 2022 to Jan 2023
measure: Stoma-specific quality of life
timeFrame: October 2022 to Jan 2023
Secondary outcomes:
measure: Stoma complications
timeFrame: October 2022 to Jan 2023
Other outcomes:
Locations:
city: Addis Abeba
country: Ethiopia
facility: Tikur Anbessa Specialized Hospital
Study officials:
affiliation: Karolinska Institutet
name: Åsa Everhov, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04107558: Healthy Volunteer Undergoing Painful Stimuli With and Without Hypnosis and Virtual Reality
Official title: Healthy Volunteer Undergoing Painful Stimuli With and Without Virtual Reality Hypnosis (VRH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Digital Sedation
Keywords: Virtual reality , hypnosis, pain, anxiety, anesthesia
Lead sponsor: Oncomfort
Sponsor class: INDUSTRY
Collaborators: name: University of Liege
First posted: 2019-09-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Subjects will undergo painful stimuli without HVR followed by a session with HVR. Subjects are their own control
Primary purpose: OTHER

Brief summary: The main purposes of this study are as follows:

Compare the effect of painful stimuli with and without Hypnosis and Virtual Reality (HVR) on healthy volunteers.

* Use of sensors and captors to monitor physiological and neurophysiological changes by painful stimulus
* Monitor level of pain and anxiety with and without HVR
* Monitor level of unpleasantness of the pain with and without HVR
* Monitor level of Anxiety, Absorption, Dissociation, Satisfaction and Comfort with and without HVR

Detailed description: The control of pain and anxiety in a hospital environment is usually managed by pharmacological means that involve a series of risks and side effects.

For many years, non-drug solutions have been of interest to the public and the care staff. The benefits of hypnosis and of virtual reality are highlighted in many studies and today allow a different approach to medicine. It is important to invest in tools that are less expensive and also effective for the well-being of the patient and the care staff. The use of a blended solution using both clinical hypnosis and virtual reality has been only scarcely documented.

Eligibility criteria: Inclusion Criteria:

- 18 years old to 70 years of age

Exclusion Criteria:

* Deaf subject
* Blind
* Non-proficiency in French (research language)
* Psychiatric disorder
* Patient under 18 years old
* Phobia of deep water
* Head or face wounds
* Claustrophobia
* Neurological disease
* Allergy to cutaneous electrodes
* Chronic pain and/or chronic analgesics consumption
* Medication affecting the autonomic nervous system
* Dizziness

Primary outcomes:
measure: Compare physiological and neurophysiological changes to painful stimulation with and without Hypnosis and Virtual Reality (HVR)
timeFrame: During the procedure
Secondary outcomes:
measure: Pain and anxiety
timeFrame: Immediately before and after the procedure
measure: Unpleasantness of the pain
timeFrame: Immediately after the procedure
measure: Absorption, Dissociation, Satisfaction and comfort, presence and cybersickness
timeFrame: Immediately after the procedure
Other outcomes:
Locations:
city: Liege
country: Belgium
facility: Université de Liège- CHU
Study officials:
References:
Clinical trial NCT06300658: Stellate Ganglion Block for Preserving Arteriovenous Fistula in Hemodialysis Patients Undergoing Major Lower Limb Orthopedic Surgery
Official title: Stellate Ganglion Block for Preserving Arteriovenous Fistula in Hemodialysis Patients Undergoing Major Lower Limb Orthopedic Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stellate Ganglion Block
Arteriovenous Fistula
Hemodialysis
Major Lower Limb Orthopedic Surgery
Lead sponsor: Aswan University
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the role of stellate ganglion blockade (SGB) for preserving arteriovenous fistula in hemodialysis patients undergoing major lower limb orthopedic surgery.

Detailed description: The best way for dialysis in chronic renal failure (CRF) patients with consideration of feasibility, rate of infection, and patency is hemodialysis by using native access by using arteriovenous fistula (AVF).

Altered calcium and phosphor metabolism in CRF patients would also increase vascular reactivity. Stellate ganglion blockade (SGB) has been used for several years for both diagnosis and treatment of circulatory problems in upper extremity. Recently preemptive SGB has been used in prevention of radial artery spasm in coronary artery patients.

SGB increases blood flow and decrease vascular resistance in the arm. SGB prevents or ameliorates the reactivity of the muscular layer of the RA in response to both surgical manipulation during harvesting the artery and to the potent vasoconstrictor mediators released during surgery

Eligibility criteria: Inclusion Criteria:

* Age 21 to 75 years.
* Both sexes.
* American Society of Anesthesiologists (ASA) physical status III.
* Chronic renal failure (CRF) patients.
* Undergoing major lower limb orthopedic surgery.

Exclusion Criteria:

* Psychiatric disorders.
* History of substance abuse.
* Ipsilateral brachial and radial artery stenosis.
* Allergy to local anesthetics.
* Cardiovascular and respiratory disorders.
* Coagulopathy.
* Use of vasoactive medications.
* Obesity (body mass index \>30 kg/m2).
* Smoking.

Primary outcomes:
measure: Fistula flow rate
timeFrame: 7th day postoperatively
Secondary outcomes:
measure: Peak systolic velocity (PSV)
timeFrame: 7th day postoperatively
measure: End diastolic velocity (EDV)
timeFrame: 7th day postoperatively
measure: Incidence of failure
timeFrame: 7th day postoperatively
measure: Adverse effects
timeFrame: 7th day postoperatively
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University
Study officials:
References:
Clinical trial NCT02089958: Standardization of Laparoscopic Hernia Repair
Official title: Standardization of Laparoscopic Intraperitoneal Onlay Mesh Augmentation for Incisional Hernia Repair: Impact on Clinical Outcomes and Quality-of-Life - Open Prospective Observational Multicentre Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Incisional Hernia
Keywords: Lapraoscopy, incisional hernia repair, mesh
Lead sponsor: Klinikum Fulda
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson
First posted: 2014-03-18
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pts. with incisional hernia following prior abdominal surgery

Brief summary: Incisional hernias are one of the most frequent complications in abdominal surgery. Laparoscopic repair is widely used but even not standardized. Existing data from different study designs show no representative data resulting in a lack of comparability and evidence. Therefore the standardization of operative techique has been proposed by the LIPOM-study group and will be assessed in a prospective manner.

Detailed description: Data are scheduled for publication.

Eligibility criteria: Inclusion Criteria:

* Primary incisional hernia
* Hernia size EHS W 1-2
* Hernia location EHS M 1-5, L 1-3
* Clinical symptoms or progressive growth of hernia

Exclusion Criteria:

* Recurrent incisional hernia
* Ventral hernie
* Hernia size \> EHS W 2
* Hernia location EHS L 4, ASA \>3
* Prospective mesh overlap \< 5 cm
* Malignant disease

Primary outcomes:
measure: Recurrence rate
timeFrame: until 12 mths postoperatively
Secondary outcomes:
measure: Pain, Quality of Life
timeFrame: until 12 mths postoperatively
Other outcomes:
measure: Wound infection
timeFrame: 12 mts postoperatively
Locations:
city: Fulda
country: Germany
facility: Klinikum Fulda
state: Hessen
Study officials:
affiliation: Klinikum Fulda
name: Achim Hellinger, MD, PhD
role: STUDY_CHAIR
References:
citation: Hellinger A, Wotzlaw F, Fackeldey V, Pistorius G, Zdichavsky M, Junemann R, Buia A. Development of an open prospective observational multicentre cohort study to determine the impact of standardization of laparoscopic intraperitoneal onlay mesh repair (IPOM) for incisional hernia on clinical outcome and quality of life (LIPOM-Trial). Contemp Clin Trials Commun. 2016 Aug 11;4:118-123. doi: 10.1016/j.conctc.2016.08.001. eCollection 2016 Dec 15.