cyrilzakka/clinical-trials huggingface dataset:
Kinesio Taping Versus Motor Relearning Program for Upper Limb

Stroke is described as rapidly developing clinical findings of localized or generalized impairment to cerebral function, with symptoms lasting 24 hours or longer, or leading to death, with no evident cause other than a vascular origin.

Stroke is a prevalent and debilitating illness that affects people all around the world. Stroke is the second or third largest cause of mortality in adults, as well as one of the primary causes of adult disability. Because the majority of stroke patients survive the initial illness, the long-term impacts on patients and their families have the greatest influence on health. Kinesiotaping is a revolutionary rehabilitation procedure. It's most typically used to treat sports injuries, however, it is progressively becoming effective in overcoming other abnormalities. Kinesio Tex tape brand is a flexible, thin, porous cotton fabric with an adhesive backing manufactured by Dr. Kenzo Kase. It provides cutaneous stimulation which facilitates or limit movement, aids in the reduction of edema, reduces pain and correct joint positions for easing muscle spasms.


Eligibility Criteria:
Inclusion Criteria:

* male and female of age 18 -60 years
* patients with post stroke duration of \>6 months
* both ischemic and hemorrhagic stroke
* modified ashworth scale of spasticity \< 3
* muscle power by manual muscle testing (MMT) ≥ 2
* no cognitive impairments by mini mental state examination (MMSE) \> 24
* cortical skin sensitivity preserved (two point discrimination, barognosis, fine and crude touch)

Exclusion Criteria:

* Participants failing to fall in this category would be excluded from the study.
* being hospitalized due to any reason other than stroke
* being subjected to treatment with botulinum toxin for \<1 year
* any other condition which affects the upper extremity
* contraindications for the application of Kinesio Taping: open wounds, skin infections such as cellulitis, allergies, skin xerosis
To Compare the Pharmacokinetics and Safety of CT-P17 and Humira in Healthy Subjects

This is a Phase 1, Randomized, Double-blind, Three-arm, Parallel group, Single-dose Study to Compare the Pharmacokinetics and Safety of CT-P17 and Humira (US licensed Humira and EU-approved Humira) in Healthy Subjects


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* BMI between 18.0 and 29.9 kg/m2, both inclusive, when rounded to the nearest tenth

Exclusion Criteria:

* A medical history and/or condition that is considered significant
* Clinically significant allergic reactions, hypersensitivity
* History or current infection of hepatitis B virus (except for past resolved infection), hepatitis C virus, human immunodeficiency virus, or syphilis
* Active or latent Tuberculosis
* History of malignancy
* Previous monoclonal antibody or fusion protein treatment, or current use of any biologic
* Planning to be pregnant or father a child or donate sperm within 5 month after administration
* Undergone treatment with an investigational drug or participated in another clinical trial within 90 days or 5 half-lives (whichever is longer)
An Open-label Study of Povetacicept in Participants With Autoimmune Cytopenias

The goal of this clinical study is to evaluate povetacicept in adults with autoimmune cytopenias of immune thrombocytopenia, autoimmune hemolytic anemia, and cold agglutinin disease to determine if povetacicept is safe and potentially beneficial in treating these diseases. During the study treatment period participants will receive povetacicept approximately every 4 weeks for 6 months, with the possibility of participating in a 6-month study treatment extension period.


Eligibility Criteria:
Key Inclusion Criteria:

1. Indication-specific Criteria

   1. Immune Thrombocytopenia (ITP)

      * Documented persistent or chronic primary ITP of at least 12 weeks duration from diagnosis to Cycle 1 Day 1
      * History of failure or relapse to at least 2 treatment regimens for ITP
      * History of exposure to a TPO-RA unless otherwise contraindicated or unavailable
      * Documented history of platelets \<30 × 10\^9/L
   2. Warm Autoimmune Hemolytic Anemia (wAIHA)

      * Diagnosis of primary wAIHA of at least 12 weeks duration documented with a current or prior positive direct antiglobulin test (DAT) for anti-IgG (±C3d)
      * Documented history of anemia with hemoglobin ≤10 g/dL
      * At least one of the following: (i) haptoglobin \< lower limit of normal (LLN) (ii) indirect bilirubin \> upper limit of normal (ULN) (iii) lactate dehydrogenase\>ULN
      * History of failure or relapse to at least 2 treatment regimens for wAIHA
   3. Cold Agglutinin Disease (CAD)

      * Diagnosis of primary CAD of at least 12 weeks duration with all of the following: (i) chronic hemolysis (ii) polyspecific DAT positive (iii) monospecific DAT strongly positive for C3d (iv) cold agglutinin titer ≥64 at 4°C (v) IgG DAT ≤1+ (vi) no overt malignant disease
      * Documented history of anemia with hemoglobin ≤10 g/dL
      * Evidence of hemolysis during screening: (i) indirect bilirubin \>ULN and (ii) lactate dehydrogenase\>ULN or haptoglobin \<LLN
      * History of failure or relapse to at least 1 treatment regimen for CAD
2. (All indications) If receiving protocol-specified standard-of-care medications, doses must be stable for protocol-specified durations

Key Exclusion Criteria:

1. Secondary AIHA, CAD, or ITP
2. Treatment with any of the following within the noted period prior to study entry

   1. rituximab: \<12 weeks
   2. IVIg: \<4 weeks
   3. sutimlimab, any use after initiation of screening is exclusionary
   4. plasmapheresis, plasma exchange, or double-filtration plasmapheresis: \<8 weeks
   5. transfusions with blood, blood products or other rescue medications: \<2 weeks
   6. splenectomy: \<12 weeks
   7. other immunomodulatory or investigational agents, except for investigational agents for COVID-19 that have been granted emergency use authorization or approved by the applicable national health authority: \<5 half-lives and requires agreement of the Medical Monitor
3. Recent serious or ongoing infection; risk or history of serious infection

Other protocol defined Inclusion/Exclusion criteria may apply.
Intensification With Enfuvirtide in Naive HIV-infected Patients (ANRS130)

HIV infection is diagnosed late in a substantial proportion of patients having an increased risk of clinical progression (AIDS, new AIDS-defining event or death). The currently recommended antiretroviral therapy has suboptimal activity in this setting and potent quadruple-drug therapy has not been sufficiently evaluated. Enfuvirtide may be an appropriate candidate as the fourth antiretroviral agent, regarding its activity, its parenteral administration avoiding gastrointestinal symptoms that often lead to interruption of treatment, the lack of pharmacokinetic interactions and the absence of systemic toxicity.

The aim of this study is to investigate, in a comparative intensification trial, the immunological benefit of adding enfuvirtide for 6 months to a conventional antiretroviral therapy in HIV-1 infected and severely immunosuppressed patients, naïve of any antiretroviral treatment.

We postulate that addition of enfuvirtide to a first-line antiretroviral therapy consisting in emtricitabine/tenofovir combined with either efavirenz or lopinavir/r may improve immunological restoration, measured as the proportion of patients with more than 200 CD4 cells per mm3 after 24 weeks of antiretroviral therapy.

The purpose of this randomized, open-label study is to evaluate the immunological efficacy of two first-line strategies of antiretroviral therapy:

1. emtricitabine/tenofovir disoproxil fumarate coformulated plus efavirenz (or lopinavir/r) intensified by enfuvirtide during the first 24 weeks of therapy.
2. emtricitabine/tenofovir disoproxil fumarate coformulated plus efavirenz (or lopinavir/r)

Patients with lymphocytes T CD4+ cell (CD4)count below 100 per mm3, or CD4 cell count below 200 per mm3 and past history or presence of AIDS defining event and naïve of any antiretroviral therapy will be eligible. This multicenter study will enroll 220 patients (n=110 in each arm). The planned duration of the study is 48 weeks from the enrolment of the last subject.

The primary endpoint will be immunological success defined as CD4 cell count above 200 cells per mm3 after 24 weeks of initial treatment. The durability of this response will be evaluated and patients will be followed for 48 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Antiretroviral naïve HIV-1 infected patients
* CD4 cell count below 100 per mm3, or CD4 cell count below 200/mm3 and past history or presence of B or C(AIDS defining)event
* Signed informed consent

Exclusion Criteria:

* Pregnancy; breast feeding
* Coinfection with HIV-2 or infection with HIV-1 subtype O
* Antiretroviral pretreated patients
* Neoplasia disease currently treated with chemotherapy or radiotherapy
* Severe liver failure
* Treatment with cytokines or HIV vaccine trial
* One or more of the following biological abnormalities: hemoglobin below 10 g/dl, Neutrophils below 750 per mm3, thrombocytopenia below 50000 per mm3, creatinine clearance below 60 ml per min, Liver Function Tests over 3 Upper Limit of Normal
The Role of Lung and Diaphragm Ultrasonography in Predicting Clinical Progression in Hypoxemic Respiratory Failure

The goal of this observational study is to evaluate whether the risk of intubation in patients with hypoxemic respiratory failure who were monitored in the intensive care unit and received non-invasive mechanical ventilation and high-flow nasal oxygen treatment could be predicted using lung and diaphragm ultrasound.

The main question it aims to answer is:

Can lung and diaphragm ultrasound predict the risk of intubation in patients with hypoxemic respiratory failure?

Between January 1, 2024, and May 1, 2024, the diaphragm thickness fraction, excursion, LUS score, ROX index, and the LUSS/ROX index ratio were evaluated using lung and diaphragm ultrasound in 91 patients admitted to the intensive care unit with a diagnosis of hypoxemic respiratory failure. These evaluations were performed at the 6th, 12th, 24th, and 48th hours of their ICU stay, and during intubation if the decision for intubation was made

Eligibility Criteria:
Inclusion Criteria:

-PaO2 \<60 mmHg detected in arterial blood gas samples at the time of admission to the intensive care unit

Exclusion Criteria:

* Under the age of 18
* History of lung and diaphragm surgery
* Congenital, acquired or traumatic diaphragmatic hernia
* Diaphragm paralysis
* Hemodynamic instability requiring vasoactive drug support
* Do not agree to participate in the study
Power Over Pain Portal: A Stepped-care Virtual Solution to Deliver Early Intervention to Canadian Youth With Chronic Pain

The COVID-19 pandemic is presenting one of the greatest threats to youth mental health seen in generations. Pain is one of the most common symptoms of extreme stress in youth. In 2020, the investigators created an online "stepped-care" program called the Power over Pain Portal. Stepped care is a promising way to improve access to CP care. Stepped care tailors care based on a person's symptom severity. Like a ladder, a person must start with one type of care then "step up" or "step down" to more or less intense care depending on need. The investigators also summarized all online pain management programs for youth to find the best resources to embed into the Portal. The investigators will pilot-test the Portal with youth to ensure it can be implemented effectively and will be clinically beneficial. The investigators will recruit 100 youth with CP to use the Portal for 2 months and see how they interact with the features and if it helps to improve their pain and mental health. The investigators will include a mixture of youth who represent different ages, sexes, genders, sexual orientations, races, dwellings, and school/employment status.


Eligibility Criteria:
Inclusion Criteria:

* Experience chronic pain
* Speak and read English
* Access to Internet / Smartphone (or will be loaned study phone with data plan)
* Intend to use the portal for 2 months

Exclusion Criteria:

* Youth self-reports:
* Receiving tertiary care or are on waitlists for tertiary care paediatric chronic pain programs
* Have moderate to severe cognitive impairment that may impact their ability to understand and use the Power over Pain Portal or complete self-reported outcomes
* Have untreated major psychiatric illness (e.g., anorexia, psychosis) and/or active suicidality at the time of screening
A Study to Follow Patients With Adult Growth Hormone Deficiency (AGHD) Treated With Sogroya® for Long Term Safety Information

In this study, the general long-term safety and effectiveness of Sogroya (somapacitan) in adults with growth hormone deficiency (AGHD) being treated per normal clinical practice is looked into. In the study, information on side effects and how well Sogroya (somapacitan) works during long term treatment in people with Adult Growth Hormone Deficiency (AGHD) will be collected and analysed. Participants will be treated with Sogroya (somapacitan) as prescribed by the study doctor, in accordance with normal clinical practice. The study will last for 5-10 years, depending on when the participant join the study. The participant will be asked to complete two short questionnaires during every visit to the clinic. The questionnaires will collect information on the participant's well-being, work ability and ability to perform daily activities.


Eligibility Criteria:
Inclusion Criteria:

1. Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
2. The decision to initiate treatment with commercially available Sogroya (somapacitan) has been made by the participant and the treating physician before and independently from the decision to include the participant in this study.
3. Male or female, age above or equal to 18 years assigned to Sogroya (somapacitan) treatment at the time of signing informed consent.
4. Diagnosis of adult growth hormone deficiency (AGHD) as per local practice.

Exclusion Criteria:

1. Previous participation in this study. Participation is defined as signed informed consent.
2. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
3. Participant with hypersensitivity to the active substance or to any of the excipients.
4. Participant with active malignancy or in treatment for active pre-existing malignancy.
5. Participant with acute critical illness, suffering from complications following open heart surgery, abdominal surgery, multiple accidental trauma, acute respiratory failure or similar conditions per investigator judgement.
A Comparison Between Two Formulations of NN5401 in Healthy Subjects

This trial is conducted in the United States of America (USA). The aim of the trial is to compare the exposure of two formulations of insulin degludec/insulin aspart (NN5401) in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Considered generally healthy upon completion of medical history, physical examination, vital signs and electrocardiogram (ECG), as judged by the physician
* Body mass index between 18.0 and 27.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to trial start
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
* Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
Labor Scale Versus WHO Partograph in the Management of Labor

This study aims to compare the novel labour scale with the traditional WHO partograph in the management of spontaneous labour in primigravida in terms of maternal and neonatal outcomes

After many centuries through which vaginal delivery (VD) had been the only safe route of birth, Cesarean section (CS) emerged as an alternative in emergency situations. CS has gradually become an appealing option for both the mother and the obstetrician and its indications increase while CS was proving safety; the rate of CS in U.S.A increased by about 50% within 10 years around the beginning of the current century. However, the increasing prevalence of CS raises questions about the impact of this trend on maternal morbidity, mortality as well as its economic burden. Accordingly, recent guidelines have been directed to revise practice-base CS indications to only situations when CS is truly beneficial to the mother and/or the fetus.

Of these indications, the most reported one was labour dystocia. The WHO partograph is a famous chart that is commonly used to observe uncomplicated labour and is almost an objective approach to guide interference. Unfortunately, the rule of the partograph in reducing the incidence of CS is questionable. Furthermore, the design of the partograph is not exactly perfect to present the process of labour. For these reasons, the labour scale was designed as a novel follow-up chart during labour. The chart considered more objective and timed management of labour with more flexible range of time based on recent evidence. A previous pilot study on 77 women suggested that the labour scale may be a good alternative to the current partograph. This study is the first randomized trial the compares the 2 charts as regards the rate of CS, maternal and neonatal health outcomes and both patient and obstetrician satisfaction.

In this clinical trial, the investigators aim to compare the labour scale to the traditional WHO partograph in terms of incidence of labor dystocia and CS as well as maternal and neonatal outcomes

Eligibility Criteria:
Inclusion Criteria:

* Primigravida
* 38 - 42 weeks of gestation
* Singleton pregnancy
* Vertex presentation
* Spontaneous labour
* Average estimated fetal weight (2500 - 3800 gram)

Exclusion Criteria:

* Maternal medical or surgical major co-morbidity
* Previous uterine scar
* Induction of labor
* Premature rupture of membranes
68Ga-PSMA-11 PET in Patients With Prostate Cancer

Patients will receive a single dose of 68Ga-PSMA-11 and undergo a PET/CT or PET/MRI imaging study.

This is a prospective, Phase III, single-center, open-label to provide extended access in patients with biochemically recurrent prostate cancer. Approximately 100 patients are planned for enrollment in this study. Patients will receive a single dose of 68Ga-PSMA-11 and undergo a PET/CT or PET/MRI imaging study.

The intervention is a PET scan with the radiolabelled Prostate-specific membrane antifen (PSMA) ligand, 68Ga-PSMA-11. The PET may be combined with a CT scan as a PET/CT or an MRI scan as PET/MRI. 68Ga-PSMA-11 PET/CT will be acquired using a modern digital GE PET/CT scanner or a modern digital PET / MRI scanner.

AEs will be collected during injection and uptake phase (45-120 min posts infusion) of Ga-68 PSMA-11 PET/CT scan. All safety events will be recorded up to 120 min post injection.

Men with pathologically proven prostate adenocarcinoma, high risk cancer at diagnosis, evidence of biochemical recurrence, or known metastatic disease planned to start and change systemic therapy regimen.

One intravenous catheter will be placed for radiopharmaceutical administration. Patients will be injected with 100 MBq (3mCi)-300 MBq( 7mCi) of 68Ga-PSMA-11 via this catheter.

Eligibility Criteria:
Inclusion Criteria:

* Histopathologically proven prostate adenocarcinoma
* Age ≥ 18 years
* Patients already diagnosed with prostate cancer: Primary Staging: intermediate and high-risk patients per NCCN guidelines
* Biochemical Recurrence: Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy):

  a. Post radical prostatectomy (RP) - AUA recommendation i. PSA greater than or equal to 0.2 ng/mL measured more than 6-13 weeks after RP and confirmed by a second determination of a PSA level of \>0.2 ng/mL b. Post-radiation therapy - ASTRO-Phoenix consensus definition i. Nadir + greater than or equal to 2 ng/mL rise in PSA
* Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

* Unable to lie flat, still or tolerate a PET/CT scan, or any other condition that would preclude PET/CT imaging.
* Patients with any medical condition or circumstance that the investigator believes may compromise the data collection or lead to a failure to fulfil the study requirements.
* Patients with known hypersensitivity to the active substance or to any of the excipients of the investigational product.
Efficacy of the SurgiStim3 Electrical Stimulation Device in Persons Undergoing Anterior Cruciate Ligament Repair

The purpose of this study is to determine whether a functional electrical stimulation device, the SurgiStim3, decreases pain, pain medications and/or edema in patients undergoing anterior cruciate ligament repair.


Eligibility Criteria:
Inclusion Criteria:

* Agree to provide informed consent to be included within this ACL study
* Demonstrate a continued willingness to be compliant with the parameters established under the study;
* Have no history of drug or alcohol abuse in the last 2 years;
* Be either a male or female adult between the ages of 18 and 64;
* Be undergoing a surgical repair of the anterior cruciate ligament (ACL) using either a hamstring, patella tendon, Achilles tendon, or allograft procedure; and
* Understand that there is no financial remuneration for participation in the study.

Exclusion Criteria:

* Pregnant women
* Insulin dependent diabetic patients
* Patients with a demand type pacemaker
* Patients who have a malignant tumor (other than basal cell epithelioma)
* Patients with a known history of alcohol or drug abuse in the last 2 years
* Patients who will not agree to provide informed consent to be included within this ACL study
* Patients who demonstrate a continued unwillingness to be compliant with the parameters established under this study.
* "Poor healers" as identified by the patient's medical history
* Patients who have a history of sensitivity to surgical tape, electrode adhesives, etc.
* Patients with a known history of RSD (reflex sympathetic dystrophy)
* Patients with a history of chronic pain (on opiates or high dosage of NSAIDS for 3 months or greater)
* Patients who have previously undergone an ACL reconstruction on the same knee
* Patients with clinically varicose veins (clinically significant or symptomatic)
* Patients whose history shows an abuse of diuretics or anti-inflammatory medications
* Patients who will undergo multiple ligament surgery (i.e., ACL plus PCL, MCL, and/or LCL)