cyrilzakka/clinical-trials huggingface dataset:
Safety & Efficacy of BCT197A2201 in COPD Patients Presenting With an Exacerbation

This study will assess preliminary parameters of safety and efficacy of a single dose of BCT197 in patients with a Chronic Obstructive Pulmonary Disease (COPD) exacerbation.

This was an exploratory, double-blind, randomized, placebo-controlled, multicenter, adaptive parallel-group design study in four parts in patients with acute COPD exacerbation. In Part I, patients were randomized to receive either a single dose of 75mg BCT197, placebo or 40 mg oral prednisone in the ratio of 1:1:1. In Part II patients were randomized to receive either a single dose of 20 mg BCT197 or placebo in the ratio of 5:1. Patients in Parts I and II received their single dose on Day 1 of the study. In Parts III and IV patients were randomized to receive either BCT197 or placebo in a ratio of 5:1 at a dose of 20mg (Part III) or 75 mg (Part IV) with patients receiving a single dose on both Day 1 and Day 6 of the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with COPD (Stage II to IV) with a COPD exacerbation.
* Smoking history of 10 pack years.
* Females must not be of child-bearing potential.

Exclusion Criteria:

* Use of steroids in the last 30 days or calcium channel blockers in the last 48 hours.

Other protocol-defined inclusion/exclusion criteria may apply
Evaluation of Osteopathic Care After Rupture of the Antero-external Cruciate Ligament of the Knee (DIDT OSTEO)

The antero-external cruciate ligament (ACL) is the ligament located inside the knee, which allows the rotation of the knee by stabilizing the femur and the tibia. Rupture of the ACL is common during the practice of certain so-called "pivot" sports, whether contact or not. It is manifested by acute pain or instability of the knee, following a crack during a twist and/or a blockage of the joint. The diagnosis will be confirmed by a clinical examination and X-rays to eliminate any fracture or tearing and by MRI to visualize the ligament rupture and the associated lesions, in particular a lesion of the meniscus.

Treatment is required because the ruptured ligament does not heal on its own and the rupture of the ligament may eventually promote the appearance of osteoarthritis. Two types of treatment can be considered, rehabilitation or surgery, depending on the patient's age and motivation to resume sports. There are several surgical techniques, the most common is to reconstruct the ruptured ligament by arthroscopy using a graft taken from the tendons of the Internal Rectus and Demi muscles tendinous (DIDT). Rehabilitation by physiotherapy is often started preoperatively and immediately after the operation, as soon as you wake up, to find a functional and painless knee. Functional recovery often depends on patient motivation.

The main objective is to show that osteopathic care in addition to physiotherapy rehabilitation improves knee functionality in patients 6 months after reconstruction of the ACL by DIDT.


Eligibility Criteria:
Inclusion Criteria:

* Patient, male or female, aged 18 to 35 inclusive
* Patient with a BMI between 18.5 and 30 kg/m² (limits included).
* Patient presenting with a total rupture of the unilateral anterior cruciate ligament (ACL).
* Candidate patient for reconstruction of the ACL with the DIDT method.
* Affiliated patient or beneficiary of a social security scheme.
* Patient having been informed and having given their free consent, enlightened and written.

Exclusion Criteria:

* Patient with damage to another structure of the knee, other than meniscal lesions.
* Patient with a contraindication to osteopathic intervention.
* Patient for whom a method other than DIDT has been proposed.
* Patient with iterative rupture of the ACL.
* Patient having undergone ligamentoplasty of the contralateral knee
* Patient participating in another research.
* Patient in period of exclusion from another research still in progress at the time of inclusion.
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.
* Pregnant, breastfeeding or parturient women.
* Patient hospitalized without consent.
Does Adding an Additional Numbing Medication Injection in the Thigh Help With Pain Control After Knee Replacement Surgery?

One common anesthetic that is performed for total knee replacement surgery is spinal anesthesia with an adductor canal regional block, which involves injecting numbing medication in the thigh region for pain control after surgery. The aim of this study is to determine whether the addition of another regional block called obturator nerve block, which involves injecting numbing medication in the upper thigh region, will improve pain control after surgery while not sacrificing mobility after surgery.

There is currently no consensus on the optimal strategy that provides the most effective postoperative analgesia while preserving ambulation and limiting side effects such as nausea and vomiting. The clinical team's hypothesis is that the obturator nerve block in addition to adductor canal block can target both the anterior and posterior distribution of nerves to the knee to provide superior analgesia while not limiting ambulation. To test this hypothesis, the clinical team will compare the rate of IV opioid consumption in patients who receive a combination of adductor canal block and obturator nerve block at the surgical site versus patients who receive adductor canal block alone.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo total knee arthroplasty
* Planned use of regional anesthesia for procedure
* Willing and able to provide informed consent

Exclusion Criteria:

* Patients on immunosuppressive therapy
* Patients with history of diabetes
* Patients with lower limb neuropathy
* Patients with history of chronic opioid use for \> 3 months, including but not limited to, fentanyl, morphine, oxycodone, methadone
* Patients with known allergy or intolerance to any drug used in the study
* Patients with history of alcohol or drug abuse
* Patients with history of intolerance of nonsteroidal anti-inflammatory drugs
* Patients with hepatic or renal insufficiency
* ASA score of 4 or greater
Hp129 Xenon Imaging and BOS in Lung Transplantation

The research is being conducted to develop new imaging methods that are sufficiently sensitive to allow for early diagnosis of BOS, a chronic allograft rejection affecting 50-60% of lung transplanted recipients who survive 5 years after transplant. Although lung transplantation has evolved into an effective therapeutic option for a large number of pediatric patients with end-stage pulmonary disease, long-term survival after lung transplantation is far worse than after the transplantation of other solid organs. This research may improve patient outcomes through earlier diagnosis of changes leading to BOS by obtaining image guided research biopsies of transplanted lung. Biopsies may be used for future research of ex vivo biomarkers of BOS and in the development of treatments through future clinical trials.

This protocol aims to

* Develop new imaging methods that are sufficiently sensitive to allow early diagnosis of BOS.
* Improve patient treatment outcomes through earlier diagnosis of changes leading to BOS by obtaining image guided biopsies of transplanted lung.
* Provide image guided biopsies for use in future research of ex vivo biomarkers of BOS and in the development of treatments through future clinical trials.

The study will achieve these aims through a prospective, non-randomized, longitudinal, observational study that will recruit about 5 subjects a year for 5 years. The study will follow these post lung transplant patients at 6 months and 1 year with 129Xe MRI (Hyperpolarized 129Xenon Magnetic Resonance Imaging) and image guided bronchial biopsies to detect early BOS and to better understand BO disease progression. The biopsies will provide future research for rapid determination of cellular and molecular mechanisms that lead to BOS and to facilitate identification and validation of translatable pharmaceutical targets.

Eligibility Criteria:
Inclusion Criteria:

* Lung Transplantation within the last 10 years or being assessed for possible lung transplantation.
* Participant must be able to hold their breath for up to 16 seconds.

Exclusion Criteria:

* Standard MRI exclusion criteria
* Bleeding disorders
* Participant is claustrophobic or otherwise unable to tolerate the imaging
* Pregnancy or positive pregnancy test
* Symptoms of respiratory infection within the past two weeks.
* Baseline oximetry at MRI visit of less than 95% on room air or less than 95% on a previously prescribed dosage of oxygen delivered by nasal cannula.
Relationship Between FMS and Trunk Muscle Strength, Balance, Body Composition.

The purpose of this study is to investigate relatationship between FMS and trunk muscle stregth, balance and body compostition


Eligibility Criteria:
Inclusion Criteria:

For Athletes

* He or she has been professionally doing sports for 5 years
* At least three training per week For Sedentary
* Sedentary people who have not regular exercises in daily life

Exclusion Criteria:

* Ankle instability
* Neurological diseases
* Surgical history (last one year)
Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)

The primary objective was to assess the efficacy of nemolizumab (CD14152) compared to placebo in participants greater than or equal to (\>=) 18 years of age with prurigo nodularis (PN) after a 16 week treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of PN for at least 6 months with: Pruriginous nodular lesions on upper limbs, trunk, and/or lower limbs, at least 20 nodules on the entire body with a bilateral distribution and Investigator Global Assessment (IGA) score more than equal to (\>=) 3 (based on the IGA scale ranging from 0 to 4, in which 3 was moderate and 4 is severe) at both the screening and baseline visits.
* Severe pruritus was defined as follows on the PP NRS:

  1. At the screening visit (Visit 1): PP NRS score was \>= 7.0 for the 24-hour period immediately preceding the screening visit.
  2. At the baseline visit (Visit 2): Mean of the daily intensity of the PP NRS score was \>= 7.0 over the previous week.
* Female participants of childbearing potential (that is \[i.e,\], fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree to use at least 1 adequate and approved method of contraception throughout the study and for 12 weeks after the last study drug injection.
* Participant was willing and able to comply with all of the time commitments and procedural requirements of the clinical study protocol, including daily diary recordings by the participant using an electronic handheld device provided for this study.

Exclusion Criteria:

* Body weight less than \< 30 kg.
* Chronic pruritus resulting from another active condition other than PN, such as but not limited to scabies, lichen simplex chronicus, psoriasis, atopic dermatitis, contact dermatitis, acne, folliculitis, lichen planus, habitual picking/excoriation disorder, sporotrichosis, bullous autoimmune disease, end-stage renal disease, or cholestatic liver disease (example \[e.g.\] primary biliary cirrhosis) or diabetes mellitus or thyroid disease that is not adequately treated, as per standard of care.
* Unilateral lesions of prurigo (e.g., only one arm affected).
* History of or current confounding skin condition (e.g., Netherton syndrome, cutaneous T-cell lymphoma \[mycosis fungoides or Sezary syndrome\], chronic actinic dermatitis, dermatitis herpetiformis).
* Participants with a current medical history of chronic obstructive pulmonary disease and/or chronic bronchitis.
* Neuropathic and psychogenic pruritus such as but not limited to notalgia paresthetica, brachioradial pruritus, small fiber neuropathy, skin picking syndrome, or delusional parasitosis.
* Requiring rescue therapy for PN during the screening period or expected to require rescue therapy within 4 weeks following the baseline visit.
* Positive serology results (hepatitis B surface antigen \[HBsAg\] or hepatitis B core antibody \[HBcAb\], hepatitis C (HCV) antibody with positive confirmatory test for HCV (e.g., polymerase chain reaction \[PCR\]), or human immunodeficiency virus antibody) at the screening visit.
Comprehensive Evaluation of the Passive Talaris Demonstrator

The passive Talaris Demonstrator (TD) is developed in continuation of previous prototypes. The main goal of the experiment is to evaluate the effectiveness of TD during daily activities.

Twenty-eight healthy active participants with an unilateral transtibial amputation will conduct 2 experimental trials (EXP1 \& EXP2) on the same day in a randomized order, i.e. EXP1 with the currently used prosthesis and EXP2 with the passive Talaris Demonstrator. Each experimental trial will include 6 minutes of treadmill walking at 3 different speeds in consecutive blocks of 2 minutes, a slope walking test, a stair climbing test, a L-test and an outdoor walking task.

The six minutes walk test (6MWT) has become one of the most widely used performance-based outcome measures of functional mobility and exercise capacity. Recently, the 6MWT has been found to correlate with single-limb balance time and symmetry of step length in people with amputation. Additionally, the 6MWT distance has been shown to be responsive to functional training interventions in people with lower-limb amputation. Six minutes of treadmill walking at 3 different speeds will be performed. This test will be performed in consecutive blocks of 2 minutes. These consecutive blocks will be walking 2 minutes at self-selected (SS) speed, 2 minutes at 75% of the SS speed and 2 minutes at 125% of the SS speed. These different walking speeds elicit different angular positions of the ankle and activation levels of muscles, and thus might alter the effectiveness of the novel device.

The slope walking test assesses the participants' ability to ascend and descend a 6 m long ramp of 10% inclination as fast as possible. For safety reasons bilateral handrails are warranted. Participants start the test in an upright position in front of the ramp and are asked to ascend the ramp, turn around on the platform, descend the ramp and return to the starting position.

The stair climbing test assesses the participants' ability to ascend and descend a staircase (84 cm total height, 3-step staircase with an average rise of 28 cm and run of 18 cm). Participants start in front of the staircase and are asked to ascend and descend as fast as possible. Again, bilateral handrails are required to allow support when needed. The ascending phase is initiated with the prosthetic side, while the first step of the descending phase is performed with the non-involved leg.

The L-test, requires higher physical activity of the user. During the L-test, participants are asked to rise from a chair, walk 7 meters, turn 90 degrees, walk 3 meters, turn 180 degrees and then return in the same way to the seated position. A total distance of 20 meter is covered.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral transtibial (below knee) amputation
* Unilateral transfemoral (above knee) amputation
* Healthy subject
* Medicare Functional Classification Level: K2-4

Exclusion Criteria:

* Any neurological disease
* Upper limb or bilateral amputation
* Stump pain or bad fit of the socket
Effect of the Innovated Seifi's Functional Appliance on Skeletal and Dentoalveolar Changes of Class II/ 1, Deep Bite

For improving the appearance of protruded upper front teeth when lower front teeth may touch palatal mucosa or have proximity to that; the innovated Seifi's Functional Appliance may be used.

Records will be obtained for each patient by the same operator before treatment and at the end of treatment. The appliance in this study is designed by Prof. Seifi and will be constructed by a well trained technician in the orthodontic laboratory of shahid Beheshti School of dentistry under the supervision of the operator. The appliance consists of a jack screw in the midpalatal region plus two Adams' clasps on the upper 1st molars and four Kimia clasps on the buccal embrasure of the upper deciduous molars or premolars. For the mandibular portion there is an incisal clasp and incisors are capped by acrylic.

The participants will be advised to use the appliance 24 hours per day except for meal times and when brushing the teeth or reading Farsi or English in class room.

Each patient will pay his/her first recall visit to the orthodontic department one week after the appliance delivery and will be instructed to turn the maxillary expansion jack screw 1:4 turn twice a week to achieve coordination of the upper and lower arches in the transverse dimension. The patients will be evaluated over one month intervals and necessary adjustments were made.

All cephalometric records, before and after treatment, will be coded and analyzed by a second party and the ultimate results and evaluations will be made.

Eligibility Criteria:
Inclusion Criteria:

* Age between 8 - 12 years old
* Class Π division 1 malocclusion (ANB\>4)
* Increased over jet (\>4mm)
* Increased overbite (\>4mm)

Exclusion Criteria:

* History of previous orthodontic treatment
* Evidence of craniofacial syndromes
Electroacupuncture for Poststroke Patients With Shoulder Pain

This is a multicenter, randomized, sham-controlled, patient- and assessor-blinded, and parallel trial to explore the effectiveness and safety of electroacupuncture (EA) therapy, compared with sham EA, for poststroke shoulder pain.

This study is aimed at showing the effectiveness and safety of electroacupuncture therapy for the stroke survivors with shoulder pain. 60 stroke survivors with shoulder pain will be enrolled in two traditional Korean medicine hospitals and randomly divided into either of verum or sham electroacupuncture group with 1:1 of allocation ratio. The participants will receive 9 sessions of electroacupuncture procedures for 3 weeks. Patients and outcome assessors will be blinded from the beginning to the study completion. Visual analogue scale will be primarily evaluated, and pain rating scale, Fugl-Meyer assessment upper extremity, modified Ashworth scale, manual muscle test, passive range of motion, Korean version of modified Barthel index, and Korean version of Beck depression inventory will be measured, too. Blinding index will be assessed. For safety, adverse events will be collected.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with cerebral hemorrhage or infarction examined by computed tomography (CT) magnetic resonance imaging (MRI) at least 2 weeks or more ago;
* complaining hemiplegic shoulder pain of VAS ≥4;
* agreeing that any treatments, including analgesics, for hemiplegic shoulder pain will not be changed from the previous 2 weeks prior to the enrollment until the last evaluation, if applicable;
* fully explained about the clinical research and sign the informed consents.

Exclusion Criteria:

* disorders, traumatic injury, or surgery of shoulders even before their stroke;
* pacemakers, embedded neural stimulator, cardiac arrhythmia, epilepsy, peripheral neural injury on their medical history;
* psychiatric disorders;
* cancer within the past 5 years, regardless of its prognosis and location;
* cognitive impairment that interferes with clinical assessment;
* hypersensitivity or fears to acupuncture;
* bleeding disorders (e.g. hemophilia or von Willebrand disease, etc.),
* pregnancy,
* difficulty in communicating with researchers, or
* any other conditions who are considered inappropriate for participating in the trial by experienced practitioners.
Fallopian Tube Sperm Perfusion (FSP) Versus Intra-uterine Insemination (IUI) in Natural Cycle

The purpose of this study is to evaluate the efficacy of fallopian sperm perfusion (FSP) in comparison with standard intrauterine insemination (IUI) in natural cycle for couples with unexplained infertility or mild male factor.

A number of randomised controlled trials have been published comparing the efficacy of FSP with standard IUI. A recent meta-analysis has suggested that in couples with unexplained infertility Fallopian tube sperm perfusion together with controlled ovarian hyperstimulation (COH) leads to increased pregnancy rates than IUI and COH. No study has been published comparing the two insemination techniques in natural cycle.

Eligibility Criteria:
Inclusion Criteria:

* infertility for at least 2 years
* age \<40 years
* unexplained infertility or mild male factor

Exclusion Criteria:

* previous assisted reproduction treatment
REPI : a Randomized Open Label Trial Evaluating the Use of APC in Pre-Implantation Reconstruction of Maxilla

This is a randomized open label trial that evaluates the efficacy of an autologous platelet concentrate (APC) in pre-implantation reconstruction of maxilla.

The sinus occlusion will be performed under general anaesthetic. On one side by the usual technique with hipbone transplant, the other side will be restored with APC mixed with autologous bone tissue removed from the surgery site.

The side selection will be determined by the randomization.

Rational

Maxillary Edentulous is one of the more frequent handicaps that cause many problems for dental prosthesis. Dental implants are currently the most convenient solution but require sufficient bone sinus height.

The filling of the sinus can be made by two ways :

* Either with autologous bone removed from hipbone or cranial bone. This method has several drawbacks such as the multiplicity of the surgery sites.
* Or with alloplasty materials that are subject to uncertain osseointegration and that are very expensive.

The aim of this study is to show the interest of an autologous platelet concentrate (APC) in this surgery. We will use the osteogenic property of platelets associated with a small quantity of spongy bone removed from the surgery site.

It has been previously demonstrated that platelets contain growth factors, in particular PDGF (platelet derivated growth factors), TGF-α1 and 2 (transforming growth factors) and IGF-1 (insulin like growth factor). These molecules have receptors on spongy bone, enhance mitosis, osteoblast differentiation, angiogenesis and induce the inhibition of osteoclats.

Method :

The sinus filling will be performed under general anaesthetic. On one side by the usual technique with hipbone transplant, the other side will be restored with APC mixed with autologous bone tissue removed from the surgery site.

The side selection will be determined by the randomization. For each patient a waiting period of 6 months is required before dental implants.

Twenty patients will be enrolled in this single-centre study with a follow-up of one year.

Main objective :

- To demonstrate that the osteogenesis with APC mixed with a small quantity (1 to 2 cm2) of autologous bone tissue removed from the surgery site, has a sufficient quality to allow the dental implants.

Secondary Objectives :

* To compare the osteogenesis with the current procedure (hipbone transplant)
* To estimate the kinetic of osteogenesis using successive radiography.

Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years
* ASA1 class of anesthetic risk
* SA3 or SA4 of the Misch classification

Exclusion Criteria:

* Smoker
* Progressive sinusal lesion or previous history of maxillary sinusitis
* Previous history of maxillary surgery
* Hemopathy
* Contraindication to cytapheresis
* Progressive cardiopathy
* Severe cerebellar arteriopathy
* Infectious state
* Thrombopenia \< 150 g/l controlled by citrate
* Serology : antibody anti-HVC, anti-HIV 1 \& 2, anti HTLV 1 \& 2 positive