cyrilzakka/clinical-trials huggingface dataset:
Diacutaneous Fibrolysis and Subacromial Syndrome

Subacromial Impingement Syndrome (SIS) is the most common cause of shoulder pain with high lifetime prevalence (one in three) in general population. In occupational population is the most common upper extremity disorder. Symptoms include pain, a variable degree of mobility limitation and a more or less pronounced functional impairment. Conservative treatment is usually the first therapeutic option and some physiotherapeutic techniques have proved its efficacy but nevertheless treatment remains challenging.

According to the investigators clinical experience, Diacutaneous Fibrolysis has a beneficial effect on patients suffering from SIS, but no one published clinical trial has evaluated this manual technique previously. The investigators hypothesis is that adding Diacutaneous Fibrolysis to a protocolized physiotherapeutic treatment can provide better outcomes. The investigators objective was to assess the effect of Diacutaneous Fibrolysis on pain, mobility and functional status in patients suffering from SIS.

A double-blind (patient and evaluator) randomized clinical trial was carried out in two public centres of Primary Health Care of the Spanish National Health System. The study protocol was approved by the Clinical Research Ethics Committee from the Jordi Gol Institute of Research in Primary Health Care and all the patients provided written consent.

A hundred and twenty patients with clinical diagnosis of SIS were included and randomly allocated to one of three groups. All groups received the same daily protocolized treatment based on therapeutic exercises, analgesic electrotherapy and cryotherapy during three weeks. Additionally, intervention group received six sessions (two a week) of actual Diacutaneous Fibrolysis; placebo group received six sessions (two a week) of placebo Diacutaneous Fibrolysis, while control group received only the protocolized treatment.

Pain intensity (VAS), active range of motion (flexion, abduction, extension, external and internal rotation) and functional status (Constant-Murley score) were measured in baseline, after the three weeks of treatment and three months after the end of treatment.


Eligibility Criteria:
Inclusion criteria:

* Over 18 years
* Diagnosed of Subacromial Impingement Syndrome
* Signed a written consent form.

Exclusion criteria:

* Damaged skin and/or cutaneous lesions in the shoulder area,
* A concomitant treatment with platelet antiaggregant agents
* Acute inflammatory conditions in the shoulder
* Previous shoulder surgery
* A pending litigation or court claim
ACCU-CHEK® Aviva Expert Study: Does Use of a Bolus Advisor Improve Glycemic Control in Patients Not Achieving Optimal Control Using Multiple Daily Injections (MDI)?

This clinical, prospective, randomized, multi-center study determined if the use of an insulin bolus advisor improves glycemic control as measured by a change in HbA1c in patients failing multiple daily injection/intensified conventional therapy (MDI/ICT).

Eligible participants were randomized to 24 weeks multiple daily injection therapy using either the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor or the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation.

Eligibility Criteria:
Inclusion Criteria:

* Must be 18 years of age or older.
* Diagnosed with Type 1 or Type 2 diabetes.
* Recent HbA1c \> 7.5% (measured within the last 6 weeks at local laboratory).
* On multiple daily injection (MDI) therapy for at least 6 months consisting of 1-2 injections per day of long-acting basal insulin (Lantus® or Detemir®) and at least 2 injections per day of regular or rapid-acting analog insulin for meal coverage.
* Subject adjusts meal insulin doses based on carbohydrate content of meals.
* Subject with Type 2 diabetes may be on stable metformin therapy (therapy unchanged during 3 months prior to study).
* Subject has been in Investigator's practice for at least 3 months but may have been seen by another physician in the practice.
* Subject has completed carbohydrate (CHO) training within the last 2 years.

Exclusion Criteria:

* Subject is on a therapy regimen that conflicts with the study:

  * Neutral protamine Hagedorn (NPH) or pre-mixed insulin;
  * oral anti-diabetic agents, with the exception of metformin;
  * injectable anti-diabetic agents other than long-acting insulin and rapid-acting insulin analogs or regular insulin (eg, fixed dose therapy);
  * use of sliding scale insulin therapy that determines insulin dosages based exclusively on specific blood glucose (bG) results.
* Subject has participated in another interventional trial within 6 weeks prior to study.
* Subject has been diagnosed with any clinically significant infectious disease or major organ system disease, such as gastroparesis or renal disease (at Investigator's discretion).
* Subject has used systemic oral or inhaled steroids for more than 7 days within the last 3 months.
* Subject is on chemotherapy or radiation therapy (self-reported).
* Subject is pregnant or lactating or is currently planning a pregnancy.
Effectiveness of Auricular Acupressure on the Methadone Patient

This study aims to investigate the effect of auricular point sticking on constipation in patients with methadone

This study is a randomized controlled trial, taking 72 methadone constipation patients from a hospital in the north as objects, and divided them into an auricular point group and a control group. The experimental group was given auricular point sticking, while the control group only used sticking cloth. The two groups were measured for constipation, TCM constitution, anxiety, depression and quality of life before the intervention and 2 weeks, 4 weeks, and 6 weeks after the start.

Eligibility Criteria:
Inclusion Criteria:

1. Methadone patients over 20 years old.
2. Those who have clear consciousness and can communicate in Chinese and Taiwanese.
3. The frequency of defecation is less than three times a week.
4. Willing to sign a written subject consent form.

Exclusions:

1. Those with wounds, broken skin, and blisters on the skin of both ears.
2. People with blood coagulation problems and related diseases, such as: purpura, hemophilia, etc.
3. Age \<20 years old.
4. Subjects who use drugs to improve constipation.
Immunomodulators on HIV-1 Reservoir

The goal of this clinical trial is to learn about the function of immunomodulators in reducing HIV reservoir. The main questions it aims to answer are:

* Are immunomodulators able to reduce HIV reservoirs?
* How do immunomodulators reduce HIV reservoirs? Participants will be randomly and equally divided into three groups, one control group and two trial groups. All three groups will continue to receive antiretroviral therapy. The two experimental groups will additionally be given different immunomodulators lenalidomide and adenosylmethionine, respectively. The effectiveness of immunomodulatory agents in reducing viral reservoirs will be explored by comparing relevant indicators in the three groups.


Eligibility Criteria:
Inclusion Criteria:

* Men and women age ≥ 18 and ≤ 65 years.
* HIV-1 infection, confirmed by any licensed rapid HIV test and then a licensed Western blot.
* Virologic suppression defined as HIV-1 RNA level below the limit of quantification prior to study entry.
* CD4+ T cell count \> 200 cells/mm3 prior to study entry.
* Ability and willingness of participant or legal representative to provide written informed consent and attend study visits as scheduled at a participating site. Willingness of participant to accept the side effects of drugs.
* All participants of reproductive potential, who are participating in sexual activity that could lead to pregnancy, must agree to use at least one reliable method of contraception from 4 weeks before the start of the study to 4 weeks after the end of the study.

Exclusion Criteria:

* Breastfeeding or pregnancy, or planned pregnancy during the study.
* Poor treatment adherence.
* Use of immunomodulators or systemic cytotoxic chemotherapy ≤ 6 months prior to study entry.
* Any current diagnosis or past history of a significant cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, neuropsychiatric, psychiatric, or other serious illness. The following laboratory values obtained prior to entry:

  * Absolute neutrophil count (ANC) ≤ 1000/mm3
  * Platelets ≤ 75,000/mm3
* Known allergy/sensitivity or any hypersensitivity to components of study drug or their formulation.
* Unwilling to provide written informed consent.
Reducing Adverse Delivery Outcomes Through Teleneonatology: A Feasibility Study

Teleneonatology, the use of audio-video communication to facilitate neonatal-perinatal care, may bridge the resuscitation quality gap by connecting centers with lower level care to experienced care providers. Using randomized trial design, this investigation will compare teleneonatal resuscitation facilitated by a neonatologist to standard resuscitation within a simulated environment.

Multiple studies have evaluated telemedicine using simulation, but the level of evidence for the use of telemedicine to improve neonatal resuscitation is low.

In this investigation and within a simulated environment, pediatric interns and residents will resuscitate a simulated 25 week infant at delivery assisted by a simulated nurse and respiratory therapist. Participants will be randomized to resuscitation performed either with or without telemedicine facilitated by a neonatologist. The primary outcome will be time to effective ventilation with other secondary outcomes including metrics derived from the American Academy of Pediatrics Neonatal Resuscitation Program.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for experienced providers include at least 3 years of pediatric and/or neonatal training, having previously performed \>10 endotracheal intubations, and may include neonatologists, pediatric fellows, and neonatal nurse practitioners. Inclusion criteria for trainees: previous exposure to NRP, an interval of \> 3 months elapsing between previous NRP applications, and may include pediatric residents, family medicine residents, nurses, respiratory therapists, neonatal fellows, and neonatal attendings.

Exclusion Criteria:

* Does not meet inclusion criteria
Changes in Brain Synchronization During Perceptual and Linguistic Tasks in Schizophrenic Patients

This study aims to identify electrophysiological correlates of impaired perceptual and linguistic processes in chronic schizophrenic patients, un-medicated first-episode schizophrenic patients and their healthy relatives.

Following administrating some questionnaires (demographic details and psychiatric history questionnaire, handedness questionnaire, reading abilities test and positive and negative symptoms questionnaire) and performing a perception test and a verbal abstract intelligence test, participants will conduct a brain scan during a series of perceptual and linguistic tasks.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for chronic patients:

* Hebrew native speakers.
* Diagnosis of schizophrenia with a history of more than one episode.
* Capable and willing to provide informed consent.

Inclusion criteria for naive patients:

* Hebrew native speakers.
* Diagnosis of schizophrenia with a history of only one episode and unmedicated.
* Capable and willing to provide informed consent.

Inclusion criteria for patients' relatives (control group 1):

* Hebrew native speakers.
* Without any psychiatric history.
* Have a child and/or a sibling with schizophrenia.

Inclusion Criteria for students (control group 2):

* Hebrew native speakers.
* Without any psychiatric history.

Exclusion Criteria:

Exclusion Criteria for patient groups (chronic and "naïve"):

* Left handedness.
* Reading disability.
* Visual perception disability.
* Brain damage and/or a history of seizures.
* Impaired intelligence.
* Metal implants.

Exclusion Criteria for control groups (family members and students):

* Psychiatric history.
* Left handedness.
* Reading disability.
* Visual perception disability.
* Brain damage and/or a history of seizures.
* Impaired intelligence.
* Metal implants.
Therapeutic Exercise Through Exergames on Mobile Devices for Cervical Rehabilitation

The objective of this study is to determine whether performing cervical therapeutic exercises using a serious game through a mobile application enhances treatment adherence compared to performing the same exercises at home following standard practice.

Participants in the study will be adults with non-specific neck pain (cervicalgia) who own a smartphone or tablet, and that give informed consent. Individuals with acute or severe conditions, such as recent surgeries or trauma, will be excluded. Before participation, they will be informed about the study and potential risks. The study is designed as a randomized clinical trial with two groups. The control group will follow a traditional home exercise program with written instructions, while the intervention group will use a personalized mobile app to guide their exercises. All participants will be asked to log their progress and any incidents in a compliance journal.

Eligibility Criteria:
Inclusion Criteria:

* Persons of legal age with cervicalgia.
* Have a smart mobile device (smartphone or tablet) on which to download the App.

Exclusion Criteria:

* Acute musculoskeletal pathological processes or exacerbation (less than 15 days of evolution). Includes presentation of symptoms such as paraesthesia, radiating pain, loss of strength in the upper limb.
* Episodes of severe pain more than 15 days of evolution.
* Accident with cervical or dorsal injury within the last month.
* Refusing to sign the informed consent.
* Not having a device suitable for installation or lack of experience in the use of smart mobile devices.
* Baseline NDI score of less than 5.
* Presence of red flags:

  * Suspicion of fracture: advanced age, previous trauma, osteoporosis.
  * Suspicion of neurological involvement: loss of sensation in extremities, loss of strength or muscle mass.
  * Suspicion of infection: fever, night sweats.
  * Suspicion of cancer: Previous history of cancer, no improvement in one month of treatment, weight loss, headache, vomiting.
  * Suspicion of systemic disease: headache, fever, malaise, general headache, fever, malaise, unilateral skin rash (herpes).
Combined Ketorolac and Lidocaine Paracervical Block for Office Hysteroscopy

A randomized double-blind placebo controlled trial comparing the effect of a combined ketorolac and lidocaine paracervical block with a standard lidocaine paracervical block on procedure related pain with office hysteroscopies.

A randomized double-blind placebo controlled trial comparing the effect of a combined ketorolac and lidocaine paracervical block with a standard lidocaine paracervical block on procedure related pain with office hysteroscopies. Primary Objective: To study the effect of a combined ketorolac and lidocaine paracervical block on procedure related pain with office hysteroscopy. Secondary Objectives: To study the effect of a combined ketorolac and lidocaine paracervical block on patient satisfaction and post procedure pain. To assess for major adverse events with the use of a combined ketorolac and lidocaine paracervical block for office hysteroscopy when compared with a standard lidocaine paracervical block. Primary Endpoint: Pain on a 100 mm visual analogue scale during cervical dilation. Secondary Endpoints: Pain on a 100 mm visual analogue scale during the paracervical block, during the office hysteroscopy, immediately after the hysteroscopy, and 30 minutes after the procedure. Other secondary endpoints include patient satisfaction, frequency of procedure termination, and adverse events. Patients assigned female at birth, booked for office hysteroscopy at Mount Sinai Hospital faculty practice associates. Patients scheduled for office hysteroscopy through seeing a Gynecologist at either 5 E 98th Street Faculty Practice Associates or 1176 5th Avenue Gynecology Practice. 5 E 98th Street primarily cares for privately insured patients, while 1176 5th Avenue cares for a mix of privately insured as well as patients insured with Medicaid. Regardless of recruitment site, all office hysteroscopies will be performed at the 5 E 98th Street facility. A randomized controlled trial designed to investigate if ketorolac added to a paracervical block reduces procedure related pain. Patient will be randomized to a standard paracervical block versus a paracervical block with ketorolac added. The study will be conducted over two years. Patients will be followed for the duration of the two-year study period.

Eligibility Criteria:
Inclusion Criteria:

* Patients assigned female at birth,
* booked for office hysteroscopy at Mount Sinai Hospital faculty practice associates.

Exclusion Criteria:

* Allergy to ketorolac or non-steroidal anti-inflammatory medications
* Allergy to lidocaine
* Presence of thrombocytopenia
* Contraindications to lidocaine
* History of gastritis or gastric ulcer
* Acute renal failure or chronic renal disease
* Chronic liver disease
* History of bleeding diathesis
* Long term narcotic use
Registry Study of Revcovi Treatment in Patients With ADA-SCID

This registry study is being conducted in patients with adenosine deaminase severe combined immune deficiency (ADA-SCID) who require enzyme replacement therapy (ERT) treatment with Revcovi. Data on safety and on measures of efficacy are collected.

Patients with ADA-SCID who require ERT will receive Revcovi on a dosage and schedule determined by the treating physician. They will be followed for safety throughout the study, and will be monitored for the efficacy markers of adenosine deaminase (ADA) activity and deoxyadenosine nucleotide (dAXP) concentration according to a suggested schedule. Some subjects will be new to ERT; some will have transitioned from Adagen, which was the ERT available before Revcovi; and some will have previously participated in an earlier Phase 3 trial of Revcovi (study STP-2279-002). Patients will be followed either until they are able to successfully undergo a stem cell transplant or stem cell gene therapy and thus no longer require ERT treatment, or until all ongoing participants have received a minimum of 24 months of Revcovi treatment.

Note: Due to the nature of this study, all analyses are descriptive and no statistical hypotheses will be tested.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged newborn to adult
* In need of ERT treatment due to one of the following circumstances:

  * Waiting to receive a stem cell transplant
  * Previously declined, had been found to be ineligible for, or did not respond to a stem cell transplant
  * Waiting to enrol in a clinical trial on gene therapy, or had been found to be ineligible for or had failed such a trial
* One of the following histories of ERT treatment:

  * Revcovi only
  * Previously on Adagen but had transitioned to Revcovi
  * Not yet on any ERT but about to start on Revcovi

Exclusion Criteria:

* Any condition that, in the opinion of the Investigator, makes the patient unsuitable for the study.
Plyometric Exercises Versus Wii Training in Children with Unilateral Cerebral Palsy

Plyometric training includes muscle contraction that moves rapidly from the eccentric to the concentric phase of movement while using proper biomechanics. It is an effective neuromuscular stimulus that can improve motor functions of children with cerebral palsy. In plyometric training, muscles exert maximum force in short intervals of time, with the goal of increasing power.

Commercially available video games have been used for a wide range of clinical populations with generally positive clinical outcomes. They have been shown to be active enough to provide an increase in energy expenditure and physical activity in children with cerebral palsy. Furthermore, an early case study showed improvements in visual-perceptual processing, balance, and mobility in a child with cerebral palsy.


Eligibility Criteria:
Inclusion Criteria:

* aged 8-12 years;
* able to understand and follow simple commands.

Exclusion Criteria:

- severe uncontrolled seizures;
Study on the Correlation of Free Vitamin d With BMD and Fracture

According to the free hormone hypothesis, the biological activity of a hormone is carried by the portion that is not bound to protein or its carrier in circulation. Based on this, we believe that the free vitamin d, which is the proportion of Vitamin D unbound to vitamin D binding protein and albumin, performs the calcium-regulating functions of the vitamin. Hence, our objective is to study whether free vitamin correlated better with BMD and fracture than the total vitamin D.

Osteoporosis is a major health issue worldwide as it increases the risk of fragility fracture and chronic disability. The studies on the association between vitamin d and osteoporosis have yielded conflicting results. While some have shown a positive correlation, others have concluded that there is no association at all. Recent reports have shown vitamin D supplementation do not prevent fragile fractures. This might be because the actual vitamin D status, which should be the free vitamin D, has not been measured.

Eligibility Criteria:
Inclusion Criteria:

* patients with a diagnosis of osteoporosis and with or without fracture
* post- menopausal women
* age \> 48 years

Exclusion Criteria:

* vitamin D supplementation in recent 6 months
* patients on steroid
* age \< 48 years
* patients with chronic diseases such as liver cirrhosis, renal failure, hypertension, hyperparathyroidism
Safety and Efficacy of Insulin Detemir in Combination With OAD in Type 2 Diabetes

This trial is conducted in Europe.

The aim of this trial is to investigate the safety and efficacy of insulin detemir combined with oral anti-diabetic drugs (OADs) versus insulin NPH combined with oral anti-diabetic drugs (OADs) in Type 2 mellitus not well controlled on current therapy on blood glucose control.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes for at least 12 months since diagnosis
* Insulin naive subjects
* OAD treatment for at least 4 months alone or combined with no more than two OADs
* Body mass index (BMI) below 35.0 kg/m2
* HbA1c between 7.5-10.0%
* Able and willing to use twice a day injections for the entire trial period

Exclusion Criteria:

* Current or previous treatment with thiazolidiones within the last 6 months
* OAD treatment with three or more OADs within the last 6 months
* Acute insulin treatment for longer than 7 days in a row within the last 6 months
* Secondary diabetes
* Known maturity onset of diabetes of young (MODY)
* Known or suspected allergy to trial product or related products