cyrilzakka/clinical-trials huggingface dataset:
Hydrocortisone in the Treatment of Intrusions in Patients With Posttraumatic Stress Disorder

To test overall efficacy of hydrocortisone on reexperience of traumatic memories (intrusions) and overall symptomatology in patients meeting criteria of complex chronic PTSD.


Eligibility Criteria:
Inclusion Criteria:

* Written Informed Consent
* Female patients with PTSD according to DSM-IV criteria (see Appendix 2).
* 18-45 years
* Intrusions (according to IES-R subscale Intrusions: Value: \> 7
* Ability of subject to understand character and individual consequences of the clinical trial
* No participation in another clinical trial (up from 30 days before this trial)

Exclusion Criteria:

* Lifetime diagnosis schizophrenia according to DSM-IV
* Mental retardation
* Body mass index \< 16.5
* Current drug and alcohol abuse and addiction
* Life-threatening self-injurious behavior in the last 4 months
* Suicide attempt with the strong intention to die in the last 4 months.
* Following diseases in anamnesis: stomach ulcera or intestinal ulcera, pancreatitis, corticoid-induced psychosis, severe osteoporosis, severe hyper-tension, heart failure, myasthenia gravis, asthma bronchiale, glaucoma, cataract, diabetes mellitus, herpes simples, herpes zoster (viremic phase), renal transplantation.
* Any pretreatment with hydrocortisone in the last 4 weeks prior to the first administration of Investiga-tional Medicinal Product.
* Following current medication: cardiac glycosides, saluretics, antidiabetics, cumarin-derivatives, rifampicine, phenytoine, barbiturates, primidone, NSAID, salicylate and indometacine, atropine, praziquantel, chloroquine, hydroxychloroquine, mefloquine, somatropine, protireline, cyclosporine, non-depolarising muscle relaxants.
* Pregnancy or lactation period
* Inadequate birth control (Adequate birth control: implants, injectables, combined oral contraceptives, intrauterine devices (IUDs), sexual abstinence or vasectomised partner)
* Shift working
* Intercontinental travel within 2 weeks prior to enrollment (to avoid jet-lag)
* History of hypersensitivity to investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
* No subject will be allowed to enrol in this trial more than once.
OPTImisation and Standardization of CIRCulating Cell-free DNA Ex-traction Protocols in a Diagnostic Setting

comparison of blood collection tubes and cell-free DNA extraction to evaluate the best possible combination to obtain high quantity and quality cell-free DNA sample for NGS analyses


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years
* no serious condition

Exclusion Criteria:

* younger than 18 years
* serious health condition that leads to higher cfDNA content in blood
Acupuncture as Treatment of Post-herpetic Neuralgia: A RCT A Double-blinded Randomized Clinical Trial.

The aim of this study is to perform the first RCT investigating the possible effect of superficial dry-needling (SDN) - a special kind of acupuncture used for PHN. The participants will be divided into two groups. Group A, the intervention group will receive SDN in the area of pain. Group B, the control group will receive a sham procedure.

The aim of this study is to investigate the possible effect of SDN on PHN. The study population consists of patients with chronic pain after herpes zoster.

The study is a controlled double-blinded randomized study. The participants will be divided into two groups, group A, the intervention group, will receive SDN in the area of pain. Group B, the control group will receive a sham procedure. The procedure will take place at the out-patient clinic at Odense University Hospital. The plan is to include 40 patients (20 in each group).

Eligibility Criteria:
Inclusion Criteria:

* Age between 50-75 years.
* Pain in the dermatomal area of the previous outbreak of HZ.
* Pain located to a dermatome originating from the thoracic or lumbar spine.
* At least six months since the outbreak.
* Understands the purpose of the study and is able to give consent.

Exclusion Criteria:

* A psychiatric illness affecting participation in the study.
* Active cancer
* Pregnancy
Effect of Oral Isotretinoin on Muscle Strength in Patients With Acne Vulgaris: A Prospective Controlled Study

BACKGROUND: Musculoskeletal side effects related to isotretinoin are frequently reported. This study aimed to investigate the effect of oral isotretinoin treatment on muscle strength. Our second aim was to evaluate whether there was a correlation between the serum creatine phosphokinase (CPK) level, a specific marker of muscle breakdown, and muscle strength.

METHODS: This study included 30 patients who presented to our hospital and were started on oral isotretinoin treatment for acne vulgaris and 30 patients in the control group who were given local treatment. Age, gender, height and weight of the patients were recorded, and the body mass index (BMI) was calculated. The hamstring and quadriceps muscle strengths of the non-dominant side were evaluated in all patients using an isokinetic dynamometer, and the peak torque (PT) values were recorded. In the isotretinoin group, isokinetic measurements were performed again in those that completed six-month drug treatment and compared with the initial PT values.

BACKGROUND: Musculoskeletal side effects related to isotretinoin are frequently reported. This study aimed to investigate the effect of oral isotretinoin treatment on muscle strength. Our second aim was to evaluate whether there was a correlation between the serum creatine phosphokinase (CPK) level, a specific marker of muscle breakdown, and muscle strength.

METHODS: This study included 30 patients who presented to our hospital and were started on oral isotretinoin treatment for acne vulgaris and 30 patients in the control group who were given local treatment. Age, gender, height and weight of the patients were recorded, and the body mass index (BMI) was calculated. The hamstring and quadriceps muscle strengths of the non-dominant side were evaluated in all patients using an isokinetic dynamometer, and the peak torque (PT) values were recorded. In the isotretinoin group, isokinetic measurements were performed again in those that completed six-month drug treatment and compared with the initial PT values.

Eligibility Criteria:
Inclusion Criteria:

* being aged 18-45 years
* receiving isotretinoin treatment for the isotretinoin group
* not having used isotretinoin within the last year for the control group

Exclusion Criteria:

* chronic kidney or liver disease,
* uncontrolled hypertension, heart failure,
* malignancy,
* thyroid and bone diseases (e.g., hyperparathyroidism and osteomalacia),
* use of drugs that may affect skeletal metabolism (e.g., corticosteroids, heparin, and anticonvulsants),
* a history of trauma and/or surgery in the lower extremities.
* Patients who discontinued or terminated their isotretinoin treatment were not included in the study.
Shoulder Innovations Clinical Data Registry

The goal of this multi-center observational study is to collect long-term clinical outcome information for anatomic and reverse total shoulder arthroplasty (shoulder replacement).

The study is a non-randomized, multi-center prospective registry that will collect standard-of-care data for patients who plan to receive or have received shoulder arthroplasty (anatomic or reverse) with a Shoulder Innovations (SI) Total Shoulder System device and consent to participate in the study. The study will evaluate short and long term clinical and radiographic outcomes associated with real-world use of the arthroplasty system from the implant procedure through 10 years post-operatively.

Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age.
2. Plan to receive or has received a shoulder arthroplasty surgical procedure, with a minimum of one implanted Shoulder Innovations (SI) device component and be willing and able to complete post-operative visits as long as at least one SI device component remains implanted.
3. Able to provide informed consent prior to enrollment in the study (unless a waiver has been obtained).
4. Agree to and be able to consistently answer the specified Patient Reported Outcome Measures (PROM) pre-operatively and at each of the post-operative visits without the use of a translator.
5. Willing and able to comply with the requirements of the study protocol

Exclusion Criteria:

1. Participation in a clinical trial of an investigational drug or device that would confound the results of this trial. Participation in another observational registry is allowed provided there are no conflicting requirements to this trial.
2. Incarceration.
3. Any conditions, co-morbidities, restrictions, or obligations that would prohibit them from complying with the requirements of this study protocol.
Far Infrared Treatment for Kidney Diseases

Renal failure or kidney failure is a situation in which the kidneys fail to function adequately. It is divided into acute and chronic forms; either form may be due to a large number of other medical problems.

There are many causes of chronic kidney disease. The most common cause is diabetes mellitus. Acute renal failure is a rapidly progressive loss of renal function, generally characterized by body fluids disturbances and electrolyte derangement.

It is believed that far infrared radiation of the central nervous system, the endocrine system and the kidneys will help in the management of renal failure and a possible cure.

Eligibility Criteria:
Inclusion Criteria:

* People with kidney diseases

Exclusion Criteria:

* None
Validation of Hand Held Indirect Calorimeter in Overweight and Obese Patients

The purpose of this study is to determine, in a group of overweight or obese volunteers, if a handheld indirect calorimeter can accurately measures oxygen consumption to determine resting metabolic rate compared to a portable indirect calorimeter.

1. Background and Rationale: With the growing number of overweight and obese Americans, health professionals need accurate and convenient tools to help personalize weight loss programs. Portable indirect calorimetry measurements are more expensive than handheld devices and often limited to research setting only, making them impractical for clinical use. Additionally equations used to estimate resting metabolic rate may be significantly inaccurate in overweight patients. Several studies have been conducted to determine the accuracy of handheld devices, however none have been done in the overweight and obese populations. If handheld calorimeters can accurately measure resting metabolic rate in overweight and obese patients, these tests may be used to improve and personalize weight management programs.
2. Key Objectives: To determine in a group of overweight or obese volunteers if a handheld indirect calorimeter can accurately measures oxygen consumption to determine resting metabolic rate.

Eligibility Criteria:
Inclusion Criteria:

* Age at least 18 years (no upper limit).
* Able to fast overnight.
* Have a BMI no less than 25 kg/m2.

Exclusion Criteria:

* All others
Research on Benefit of Umooze as Add- on Therapy in Benign Prostatic Hyperplasia

To evaluate the improvement in symptoms of Benign Prostatic Hyperplasia (BPH) according to the Prostate Symptom Score (IPSS) and Quality- of- Life (QoL) index after add- on therapy of Umooze twice daily administration for 56 days in patients with BPH.

The study product, Umooze, contain Astragalus radix extracts and Soy extracts as the combination of 960:40 in one 500 mg tablet. Umooze is sold in the market as food. The objective of this study is to evaluate the benefit of Umooze as add- on therapy in BPH, by evaluation the improvement in symptoms of BPH assessed according to the International Prostate Symptom Score (IPSS) and Quality- of- Life (QoL) index after add- on therapy of Umooze in patients with BPH. The IPSS is a validated 7-item urinary symptom severity scale.

A randomized, two-regimen, placebo-controlled, parallel- design is used in this study in which each subject will receive Umooze or placebo. The add- on study product will be administered twice daily for 56 days. Benefit will be evaluated at baseline and subsequently on the study day 28, 42, and 56, such as IPSS index, QoL index, Qmax, PVR, prostate volume and Prostate-specific antigen(PSA).

Eligibility Criteria:
Inclusion Criteria:

* Males aged \>=40 years old
* Screened by inquiry and diagnosed as BPH based on the result of a digital rectal examination (DRE) or transrectal ultrasonography (TRUS)
* Prostate volume \>= 20 cm3
* Has complained of voiding symptoms related to BPH
* Has an IPSS \>= 13 or an UFR measure of Qmax \<= 15 ml/sec together with a voided volume \>= 150 ml.
* Serum PSA \< 6.5 ng/ml
* Has been treated with medication for BPH
* Informed consent form signed.

Exclusion Criteria:

* Sensitivity to study product
* Had received prostatic surgery for BPH during the past 24 weeks
* Hard nodule found by DRE
* Ongoing neurogenic bladder, urinary tract infection, bladder stone, urethral stricture, bladder cancer, prostate cancer, severe liver dysfunction, severe renal dysfunction or severe cardiovascular disease.
* Patient has clinically significant physical disability or abnormal findings on physical examination or laboratory testing judged by the investigator or co- investigator.
* Participation of any clinical investigation during the last 30 days.
* Individuals are judged by the investigators or co- investigator to be undesirable as subjects.
Efficacy and Safety of Losartan in Children With Ig A Nephropathy

The investigators hypothesize that using Losartan would help decrease proteinuria in controlling proteinuria in children with immunoglobulin A nephropathy.

Twenty nine patient with IgA nephropathy with proteinuria (urine protein to creatinine ratio \> 0.3 mg/mg) were included in the study. All patients had received losartan treatment for 24 weeks. Changes in blood pressure, proteinuria, renal function, and biochemical parameters were prospectively evaluated before and at 4 weeks and 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age: 2years or older and younger than 18 years
* Biopsy-proven Ig A Nephropathy
* Estimated GFR ≥ 90mL/min/m\^2
* Mean urinary protein-creatinine ratio \> 0.3 g/g from three first-morning spot urine collections

Exclusion Criteria:

* hypertension
* under dialysis or organ transplanted
* bilateral renal artery stenosis
* primary hyperaldosteronism
* pregnant
HIPACE High Frequency Low Energy Pacing to Terminate Fast Ventricular Arrythmias

People that have survived, or are at high risk of a lifethreatening ventricular arrhythmia are routinely offered a defibrillator (ICD). An ICD is an implanted device which can recognise a ventricular arrhythmia and then try to treat it, either by rapidly pacing the heart or by shocking the heart. Currently, very fast ventricular arrhythmias, known as VF, can only be treated with a shock. Patients find shocks painful and this study is intended to find out whether it is possible to pace the heart at very high rates during VF. It is hoped that if this is possible, further research could lead to effective treatment of VF with pacing rather than shocks, and therefore better outcomes for patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient is older than 18 years of age; Any patient with a Medtronic cardiac implantable defibrillator undergoing defibrillation testing; No contra indication to defibrillation testing Patient is able to give informed consent.

Exclusion Criteria:

* Patient is younger than 18 years; Patient is not able to give informed consent or is unwilling to participate in the study; Patient has a contraindication to defibrillation testing
ReSET for the Treatment of Stimulant Use in HIV Clinics: Care Optimization Supporting Treatment Adherence (COSTA)

The purpose of this study is to find out if reSET, an FDA authorized mobile therapeutic, is effective in treating stimulant use disorder and helping keep HIV viral load suppression stable among men who have sex with men who are living with HIV and have a stimulant use disorder.


Eligibility Criteria:
Inclusion Criteria:

* Identifies as male or as a female, who was assigned male sex at birth and who has not undergone any hormonal Treatment;
* Reports past year anal intercourse with a male, or identifies as a man who has sex with other men;
* Age 18 or older (reSET is only approved for use with adults);
* Person Living with HIV who is an Aids Healthcare Foundation (AHF) patient at one of the four metro areas: Atlanta, Dallas/Fort Worth, Fort Lauderdale, Los Angeles;
* Screens positive for a moderate or severe stimulant use disorder in the last 3-months using the Alcohol, Smoking and Substance Involvement Test (ASSIST);
* Reports that he is not currently in drug Treatment;
* Currently has an active Antiretroviral Therapy prescription and reports \< 90% HIV Tx adherence on the 3-item Wilson measure in the past 30 days69;
* Has an iPhone, Android smartphone or a tablet computer;
* Can obtain access to stable internet with privacy acceptable to the participant at least twice a week\*
* Indicates being able to understand English (reSET is only available in English; can be read or heard);
* Consents to participation in the study.

Exclusion Criteria:

* Otherwise eligible participants will be excluded if they appear to have diminished capacity to consent either because of cognitive impairment or severe psychiatric symptoms (e.g., mania, psychosis).
* Patients who can benefit from another type of Treatment because of severity of Stimulant Use Disorder or opiate use disorder will be referred appropriately.
* We will exclude persons residing in criminal justice facilities because they will not have access to a mobile device as required by reSET.
NORMAL HUMAN IMMUNOGLOBULINS (IVIG) IN PATIENTS AGED 75 YEARS AND OVER, COVID-19 WITH SEVERE ACUTE RESPIRATORY FAILURE

According to recent data, death rate is more than 20% for 75 years old hospitalized patients and older.

In case of aggravation, according to the latest observations, if they are refused for mechanical ventilation in intensive care, their death rate could reach 60% even for patients without comorbidity.

Apart from an increase in oxygen therapy, no specific treatment is currently proposed.

The control of the inflammatory component seems to be a key element to be able to influence the patients' health evolution.

Polyvalent intravenous immunoglobilins have immunomodulatory and anti-inflammatory properties with a favorable safety profile for these elderly patients and several clinical cases lead to positive impact in the caring for Covid patients.

This study objective is evaluation of the efficacy of polyvalent IVIg in combination with the standard management of patients aged 75 and over with SARSCov2 infection with acute respiratory failure (saturation ≤ 95%) requiring oxygen therapy\> 5 L / min (i.e. patients considered as moderate to severe ARDS according to the Berlin definition, Pa02 / Fi02≤200) and disqualified from a care in the ICU.


Eligibility Criteria:
Inclusion Criteria:

* Man or woman aged 75 and over
* SARS-coV2 infection confirmed by RT-PCR or thoraco-pulmonary CT
* Hospitalized in the acute general geriatrics unit of the Versailles Hospital Center
* Patient rejected from resuscitation
* Saturation ≤ 95% under oxygen therapy\> 5 L / min (i.e. PaO2 / FiO2≤200mmHg according to the Berlin definition of ARDS) by means of a nasal cannula, a high concentration facial mask or another device similar oxygen distribution

Exclusion Criteria:

* Patient under palliative care
* Patient with contraindication to IV polyvalent Ig

  1. . Hypersensitivity to the active substance or to any of the excipients (L-proline)
  2. . Hypersensitivity to human immunoglobulins, especially when the patient has anti-IgA antibodies,
  3. . Patients with type I or II hyperprolinemia
* Patient under guardianship or curatorship
* Patient receiving another experimental treatment as part of an interventional study
* Moderate to severe dementia known: it must have been diagnosed before hospitalization and is defined by an MMSE \<20/30 or a neuropsychological assessment with a diagnosis made.
* Patient not affiliated with a social security system in France
* ADL patients \<4/6 and / or IADL \<6/8
Efficacy of Acupuncture in Refractory Irritable Bowel Syndrome

The trial aims to examine the efficacy and safety of acupuncture in the treatment of refractory irritable bowel syndrome (IBS). The investigators will include 170 participants to receive acupuncture plus usual care or sham acupuncture plus usual care. Twelve sessions of acupuncture will be delivered to participants over a period of 4 weeks. The primary outcome is defined as proportion of participants with adequate relief of global IBS symptoms at week 8, which is defined as \>50% reduction in IBS-SSS scale.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-70 years (either sex);
* Fulfilled Rome IV criteria for IBS;
* Patients with normal occult blood in stool in recent one month;
* The age is above 50, the results of colonoscopy are normal in near year;
* Symptoms are present for ≥12 months;
* There is an absence of response to a minimum of 6 weeks of dietary intervention or advice;
* There is an absence of response to an adequate dose of at least one conventional pharmacological agent tried for a minimum of 6 weeks;
* Signed the written informed consent form.

Exclusion Criteria:

* Previous colonoscopy, meal barium fluoroscopy, abdominal ultrasound and other examinations found severe intestinal organic lesions (including but not limited to ulcerative colitis, familial multiple intestinal polyps, colorectal cancer patients);
* The presence of one or more of the following warning symptoms: unexplained rectal bleeding, a positive faecal occult blood test result; anaemia, abdominal mass, ascites, fever, and emaciation;
* The presence of other severe medical conditions, such as cardiovascular disease, endocrine disorders, hepatic dysfunction, renal diseases, and cognitive disorders that can affect the outcome assessment results;
* Unconscious, unable to express subjective symptoms of discomfort and clearly diagnosed severe mental disorders;
* An unstable psychological state or accompanying psychological disorders (SDS\>56);
* With pregnancy or lactation;
* Accepting acupuncture treatment in the last 3 months;
* Difficulties in attending the trial, such as fear of acupuncture.
Ultrasound-guided Neuromodulation Percutaneous in Lower Back Pain

In our daily clinical practice, one of the most frequent reasons for consultation physiotherapists is low back pain (LBP). Regardless of the origin of the problem, the approach from physiotherapy contemplates the reduction of pain through different procedures, including neuromodulation.

In the field of Physiotherapy, ultrasound-guided Percutaneous Neuromodulation (PNM) is defined as the application through a needle with ultrasound guidance of an electrical current at low or medium frequency, seeking a sensitive and / or motor response of a peripheral nerve in some point of its trajectory, or of a muscle in a motor point, with a therapeutic objective. The objective of this study is to analyze that the effect of PNM on the sciatic nerve produces statistically significant changes in pain, joint range and functionality in patients with chronic LBP. Thirty subjects will be recruited, which will be divided into 3 groups: group 1 to which PNM will be applied to the sciatic nerve in the gluteus region; group 2 to which PNM will be applied to the sciatic nerve in the middle of the thigh; and group 3 to which PNM will be applied to the sciatic nerve before popliteus region. The PNM intervention with NMP will consist in the single application of an asymmetric rectangular biphasic current (250 microseconds, 3 Hz) during 90 seconds


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Lower Back Pain
* Having no other therapy

Exclusion Criteria:

* Other pathology (discal hernia, injured limbs, neurological pathology)
* Belenophobia