cyrilzakka/clinical-trials huggingface dataset:
The Effectiveness of Osteopathic Manipulative Medicine in the Management of Headaches Associated With Post Concussion Syndrome

Pilot study looking at the Osteopathic Manipulative Treatment (OMT) for various headache types in patients with post-concussion syndrome (PCS). Twenty-six subjects with symptoms lasting \>3 months were enrolled and were randomly assigned to a treatment group (n = 13) and a control group (n = 13).

Evidence shows the effectiveness of Osteopathic Manipulative Treatment (OMT) for various headache types, with limited evidence of its use for headaches related to mild traumatic brain injury (MTBI). No studies were found regarding OMT for headaches in patients with post-concussion syndrome (PCS), defined as symptom persistence \>3 months after MTBI.

Objective: To evaluate OMT for headaches in patients with PCS. Methods: A controlled pilot study was conducted of patients with PCS who presented to an outpatient interdisciplinary rehabilitation clinic. Twenty-six subjects with symptoms lasting \>3 months were enrolled and were randomly assigned to a treatment group (n = 13) and a control group (n = 13). Primary outcome measures were 1) immediate change in headache scores with a visual analog scale (VAS) and 2) change in the 6-item Headache Impact Test (HIT-6) between baseline and follow-up visits. 10 control participants completed HIT-6 between baseline and follow-up visits but did not receive OMT and did not complete VAS. After OMT, immediate VAS changes in treatment group and the improvements in HIT-6 scores for both groups between baseline and follow-up were analyzed for statistical significance.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of mild traumatic brain injury (MTBI),
* age 18 years or older
* injury occurring \>3 months prior, and
* headache as a primary symptomatic concern.

Exclusion Criteria:

* history of moderate to severe traumatic brain injury (TBI),
* documented intracranial injury,
* chronic headache or migraine headache before the injury,
* treatment with a headache specialist at the time of injury, or receipt of IV infusion for medication for headache at the time of treatment.
Deep Brain Stimulation of the Superolateral Branch of the Medial Forebrain Bundle (slMFB) for the Treatment of Refractory Major Depression

The investigators will investigate in a sham controlled staggered onset design antidepressant effects and safety of deep brain stimulation (DBS) to the superolateral branch of the main medial forebrain bundle (slMFB).

The target point for DBS in major depression disorder is located lateral to the ventral tegmental area (VTA) in the midbrain at the branching point of the superolateral branch (slMFB) from the main medial forebrain bundle (MFB).

The exact stimulation coordinates are:

Montreal Neurologic Institute brain 152 coordinates (MNI152 coordinates):

left: x(lat.)=-5, y(ap)=-14, z(vert.)=-8 right: x(lat.)=5, y(ap)=-14, z(vert.)=-9

Mid-commissural point coordinates (MCP coordinates):

eft: x(lat.)=-6, y(ap)=-1, z(vert.)=-6 right: x(lat.)=4, y(ap)=-1, z(vert.)=-7

All coordinates refer to the MNI152 brain.

Legend:

slMFB = superolateral branch of medial forebrain bundle lat. = lateral, ap= anteroposterior, vert. = vertical.

More information can be found at: http://goo.gl/n9sWV

Eligibility Criteria:
Inclusion Criteria:

* Major depression (MD), severe, unipolar
* German mother tongue
* Age 20 to 75 Years
* Hamilton Depression Rating Scale (HRSD24) score of \> 21
* Global Assessment of Function (GAF) score of \< 45
* At least 4 episodes of depression or chronic episode \> 2 years
* Failure to respond to

  * adequate trials (\>5 weeks at the maximum recommended or tolerated dose) of primary antidepressants from at least 3 different classes;
  * adequate trials (\>3 weeks at the usually recommended or maximum tolerated dose) of augmentation/combination of a primary antidepressant using at least 2 different augmenting/combination agents (lithium, T3, stimulants, neuroleptics, anticonvulsants, buspirone, or a second primary antidepressant);
  * an adequate trial of electroconvulsive therapy (ECT) (\>6 bilateral treatments) and; an adequate trial of individual psychotherapy (\>20 sessions with an experienced psychotherapist)
* Able to give written informed consent
* Compliance to participate in the study
* Drug free or on stable drug regimen at least 6 weeks before study entry

Exclusion Criteria:

* Current or past non-affective psychotic disorder
* Any current clinically significant neurological disorder or medical illness affecting brain function, other than motor tics or Gilles de la Tourette syndrome
* Any clinically significant abnormality on preoperative magnetic resonance imaging (MRI)
* Any surgical contraindications to undergoing DBS
* Current or unstably remitted substance abuse (aside from nicotine)
* Pregnancy and women of childbearing age not using effective contraception
* History of severe personality disorder
* Acute suicidal tendency
ERr 731® Formulation Evaluation

A comparison of an enteric coated and micro-coated formulation of ERr 731®

Current clinical and commercialization experiences have been with enteric-coated formulations of ERr 731®. With the demonstrated safety of this formulation and the absence of anthraquinones in the extract, there is interest in launching a micro-coated, but not enteric-coated, formulation to broaden the commercial availability of ERr 731® in new markets. It is proposed that a double-blinded, randomized cross-over design in a peri-menopausal/menopausal and preferably symptomatic group of women (target population for commercialization) is best suited to demonstrate equivalent tolerability.

Eligibility Criteria:
Inclusion Criteria:

* Ages 35-64, inclusive, preference given to Subjects Ages 45-54, inclusive
* Preference given to symptomatic Subjects; symptoms including vasomotor symptoms, mood disturbances, fatigue, myalgias and arthralgias.

Exclusion Criteria:

* A serious, unstable illness including cardiac, hepatic, renal, gastrointestinal, respiratory, endocrinologic, neurologic, immunologic/rheumatological, or oncological/hematologic disease.
* History of Breast or Uterine cancers.
* Known infection with HIV, Tuberculosis or Hepatitis B or C.
* Hormone Replacement Therapy: All formulations of synthetic estrogens, natural estrogens (estrone, estradiol and estriol) and progestins (including natural progesterone)
* Hormonal Contraceptives: All formulations of synthetic estrogens and progestins
* Botanical Formulations - including phytoestrogens and progesterone-mimetic botanicals (Rhapontic Rhubarb, Soy Phytoestrogens, Hops (8-prenyl naringin) Red Clover, Kudzu, Chaste Tree Berry, Licorice, Resveratrol, Black Cohosh, Dong Quai, etc.)
* Use of Narcotics during the last 30 days
* Use of Anticoagulants during last 30 days
* Use of Corticosteroids during the last 30 days
* Use of controlled substances (other than marijuana or CBD) on a recreational basis during the last 30 days.
* Consumption of more than 3 alcoholic beverages per day (One beverage is a 5-ounce glass of wine, 12 ounces of beer, or one ounce of hard liquor)
* Pregnancy
* Breast Feeding
Serrantor OCT Study

TA prospective randomized control trial to evaluate the serration angioplasty effect in BTK arteries with varying degrees of calcified plaque.


Eligibility Criteria:
Inclusion Criteria:

* Rutherford clinical category 4-6 of the target limb
* Age of subjects is \>18 years old
* Patients has given informed consent to participate in this study

Exclusion Criteria:

* De novo or restenotic (without prior stent) stenosis (≥70%) or occlusion
* Target lesion is in the BTK arteries, including below the knee popliteal, tibioperoneal trunk, tibial, peroneal, and pedal arteries.
* Angiographic visual estimated reference vessel diameter is between 2.0 and 5.0 mm.
* Lesion length less than 220 mm
Inhaled Beta-2 Agonist Versus Epinephrine For Treatment of Transient Tachypnea of Newborn (TTN)

Inhaled Beta-2 Agonist Versus Epinephrine For Treatment of Transient Tachypnea of Newborn: Randomized controlled trial to assess:

This is a randomized double-blind randomized controlled trial. It had been conducted at the Neonatal Intensive Care Unit (NICU) of Mansoura University Children's Hospital, Egypt Written informed consent had been taken from all parents whose infants were recruited in the study. The ethics committee of the faculty of medicine has approved the study.

Eligibility Criteria:
Inclusion Criteria:

* babies with 35 weeks of gestation or more in the first 6 hours of life diagnosed with TTN according to the criteria of which are:

  * Tachypnea (respiratory rate exceeding 60 breaths/ min) within 6 hours after birth
  * Persistence of tachypnea for at least 12 hours
  * Mild cyanosis, nasal flaring, or retractions.
  * Chest radiograph indicating at least one of the following:
* Prominent central vascular markings
* Widened interlobar fissures
* Symmetrical perihilar congestion
* Hyperaeration is evidenced by flattening and depression of the diaphragmatic domes.

Exclusion Criteria:

* Newborn infants with gestational age \< 35 weeks
* Meconium aspiration
* Respiratory distress syndrome
* Pneumonia
* Congenital heart diseases including persistent pulmonary hypertension of the neworn (PPHN)
* Sepsis or suspected sepsis
* Polycythemia
* Newborn infants with congenital malformations and chromosomal anomalies
* Newborn infants with ventilatory support.
* Newborn infants with arrhythmia
Lenalidomide-Adriamycin-Dexamethasone (RAD) Induction Followed by Stem Cell Transplant in Newly Diagnosed Multiple Myeloma

Subjects up to the age of 65 years with newly diagnosed multiple myeloma requiring treatment are eligible. Minimal pretreatment (2 cycles of chemotherapy; local irradiation; surgery) is permitted. After enrollment, patients are to receive four cycles of RAD induction treatment: a combination of lenalidomide (Revlimid), adriamycin, and dexamethasone. If at least a minimal response is achieved to RAD, they will undergo chemomobilization (cyclophosphamide, etoposide) of peripheral blood stem cells and one uniform cycle of high-dose melphalan chemotherapy followed by a first stem cell transplant. If any of the high-risk features (such as elevated beta 2-microglobulin, adverse cytogenetic factors, elevated LDH, Ig A isotype) were present at diagnosis, patients will be allocated to a consolidative allogeneic transplant following dose-reduced conditioning. If no appropriate donor is available, the patient does not consent or lacks of high-risk features a second autograft following high-dose melphalan will be delivered. All patients will proceed to lenalidomide maintenance (one year) following hematopoietic reconstitution.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Newly diagnosed multiple myeloma
* Maximum of one prior systemic therapy (2 cycles)
* Presence of CRAB criteria
* Measurable disease parameters
* Left ventricular ejection fraction at least 55%
* DLCO of at least 60%
* Adequate bone marrow function
* Use of adequate contraception for female subjects with childbearing potential and all male subjects
* Eligible for autologous and allogeneic stem cell transplantation
* Bone marrow baseline sample evaluable for interphase cytogenetics

Exclusion Criteria:

* Any serious medical conditions preventing the subject from written informed consent
* Progressive disease (PD) to any initial treatment
* Pregnant or lactating females
* Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data
* Use of any other experimental drug or therapy within 28 days of baseline
* Preexisting neuropathy of ≥ grade 2 severity
* Known hypersensitivity to thalidomide
* Any prior use of lenalidomide
* Positive for HIV or infectious hepatitis, type A, B or C after serologic testing
* Serum creatinine despite induction therapy ≥ 2.0 mg/dL
Hand Exercises for Women With Rheumatoid Arthritis and Impaired ADL Ability: an Exploratory Trial

The study examines whether hand exercise therapy as an add on to a compensatory intervention program focused on joint protection, assistive devices and alternative methods of doing will improve the performance of ADL tasks requiring hand function in patients with rheumatoid arthritis (RA).


Eligibility Criteria:
Inclusion Criteria:

* Female sex.
* Age ≥ 18.
* Diagnosis of rheumatoid arthritis (2).
* Involvement of the hands, due to minimum one tender wrist, metacarpophalangeal (MCP) or proximal interphalangeal (PIP) joint in one of the hands.
* Be on stable medication for at least 3 months prior to participation.
* Self-reported decreased ability to perform personal and instrumental ADL tasks involving the hands.

Exclusion Criteria:

* Significant osteoarthritis of the hand assessed at the initial examination by the rheumatologist
* Hand surgery within 6 months of study participation
* Other pain condition involving muscles and/or joints, e.g. fibromyalgia.
* Prednisolon therapy, change in dose of biological agent or start of treatment with a new biological agent within the last 3 month before study start.
* Inability to understand the information or to speak Danish
* Any other condition that in the opinion of the investigator or accessing rheumatologist puts an otherwise eligible participant at increased risk by participation or otherwise make the person unfit for participation.
poSt Covid-19 Infection centraL Sensitisation 2

The aim of this study is to evaluate whether there are indicators of central sensitisation in patients post covid-19 infection.

The COVID-19 pandemic is currently a serious global public health concern. This disease is caused by a novel coronavirus which was first discovered in Wuhan, China in 2019 and later spread rapidly throughout the world. Symptoms of the disease can manifest as fever, cough, encephalitis, myalgia, fatigue, muscle weakness, arthralgia, anosmia, and impairment in other bodily functions in the acute phase. In 17% to 67% of cases, COVID-19 patients will develop acute respiratory distress syndrome (ARDS) and critical illness. Besides the impact on the respiratory system, coronaviruses have an effect on other systems including the central nervous system, cardiovascular system, musculoskeletal system, and gastrointestinal system.

The term central sensitivity syndrome (CSS) describes a group of medically nonspecific disorders, such as fibromyalgia, chronic fatigue syndrome, and irritable bowel syndrome, for which central sensitivity might be a common etiology. Despite the lack of a solid outcome measurement, the Central Sensitization Inventory (CSI) was previously introduced as a screening instrument for clinicians to help identify patients with a CSS. Furthermore, quantitative sensory testing can be used to identify and quantify sensory disfunctions by evaluating a variety of parameters including pain thresholds, temporal summation, and conditioned pain modulation (CPM). Previous research in patients with chronic pain resulted in less efficacious CPM, increased nociceptive facilitation and decreased pain thresholds.

In post covid-19 patients, potential long-term secondary effects on the musculoskeletal system such as muscle weakness, decreased muscle mass, and myopathies have been brought under attention. Persisting symptoms are a frequently reported complaint in patients recovered from COVID-19 infection with at least 1 symptom, particularly fatigue and dyspnea. Fatigue is also one of the core symptoms in central sensitisation disorders, leading to the hypothesis that central sensitisation might be the underlying common etiology in chronic pain patients and patients post COVID-19 infection. Therefore, the aim of this study is to evaluate whether there are indicators of central sensitisation in patients post covid-19 infection.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosed covid-19 infection that took place 2-8 weeks before study inclusion.
* Cognitive and language functioning enabling coherent communication between the researcher and the participant.
* French-or Dutch speaking persons.

Exclusion Criteria:

* Covid-19 infection \> 8 weeks ago.
Investigation to the Mechanism of the Neuroplastic Modulation in Central Auditory Tract

Tinnitus is the awareness of sound or noise in the absence of acoustic stimulation. No definite therapeutic strategy of tinnitus has been developed yet. The current theory of tinnitus is the plasticity theory of neurophysiology model. Although acupuncture has its role in tinnitus treatment, its actual role still remains to be elucidated. Acupuncture has been proposed to induce the development of neuroplasticity. The aim of this project is to undergo a comprehensive investigation to the central auditory effect and the therapeutic effects of acupuncture in tinnitus. According the results of the preliminary studies, the objective auditory measurement and subjective tinnitus perception will be analyzed in tinnitus patients before and after acupuncture.

Hearing loss is a common sensory deficit in human beings. Besides communication handicaps, hearing loss may associate with niggling tinnitus symptoms. Tinnitus is the awareness of sound or noise in the absence of acoustic stimulation. Tinnitus may cause bothersome problems in cognition, mood, or psychosocial behaviour and constitute a significant portion in the outpatient clinics of ENT practice. No definite therapeutic strategy of tinnitus has been developed yet. The current theory of tinnitus is the plasticity theory of neurophysiology model. According to this theory, several neuromodulation methods have been proposed such as repetitive transcranial magnetic stimulation (rTMS) or vagus nerve stimulation (VNS). Although acupuncture has its role in tinnitus treatment, its actual role still remains to be elucidated. Acupuncture has been proposed to induce the development of neuroplasticity. There are still few thorough researches to investigate the neurophysiological events after acupuncture. The aim of this project is to undergo a comprehensive investigation to the central auditory effect and the therapeutic effects of acupuncture in tinnitus. According the results of the preliminary studies, the objective auditory measurement and subjective tinn itus perception will be analyzed in tinnitus patients before and after acupuncture. The ultimate results of this project will clarify the basic central auditory effects of acupuncture and provide a potential for translational application of acupuncture to treat the common tinnitus patients.

Eligibility Criteria:
Inclusion Criteria:

* 18-30 y/o
* Normal hearing
* No acupuncture contraindication

Exclusion Criteria:

* Heart disease or other acupuncture contraindication
* Bleeding tendency
* Autoimmune disease
* Drug abuse
* Pregnant or breast-feeding
* Hearing loss
* Active otitis media or inner ear diseases or retro-cochlear pathology
* Incomplete treatment
Pilot Study of Safety and Tolerability of Nutrifriend Cachexia in COPD Cachexia

SF-K002 is a pilot study in patients with moderate to severe COPD suffering from involuntary weight loss. The study is 12 weeks, double-blinded, placebo controlled and the main objective is to study the safety and tolerability of Nutrifriend Cachexia.

This study is a 12-week, randomised, parallel group, placebo controlled, multi-centre study. The primary objective is to evaluate the safety and tolerability of Nutrifriend Cachexia in patients with COPD. The secondary objectives of the study are to evaluate effects on body composition, muscle function, daily activity, inflammation, lung function, compliance, appetite and Quality of Life.

Eligibility Criteria:
Inclusion Criteria:

* Age \>50 years
* Moderate to severe COPD patients with forced expiratory volume (FEV1) of 30-60%
* Involuntary weight loss \<10%
* 18 kg/m2 ≤ BMI ≤ 32 kg/m2

Exclusion Criteria:

* Exacerbation of COPD within 3 months prior to screening
* Treatment with oral corticosteroids (\>5 mg/day) within 3 months prior to screening
* Treatment with anabolic steroids within 3 months prior to screening
* Current oxygen treatment or home ventilation therapy
* Change in smoking habits during the previous 6 months
* Major changes in COPD maintenance treatment within 3 months prior to screening
* Other cachectic disorders such as cancer, renal or hepatic disorders
A Phase I Study of E7050 in Subjects With Solid Tumors

The purpose of this study is to investigate the tolerability, safety, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of E7050 when administered orally once daily to patients with advanced solid tumor and gastric cancer.


Eligibility Criteria:
Inclusion Criteria

1. Aged from 20 to less than 75 years old at the time of obtaining informed consent.
2. Histological or cytological diagnosis of solid tumors.
3. Subjects who have progressed after treatment with approved therapies or for whom there are no standard effective therapies available.
4. Adequate organ function.
5. Subjects who have no carryover of effect from prior therapy or no adverse drug reactions (excluding alopecia) that may affect the safety evaluation of the investigational drug.
6. Performance Status (PS) 0-1 established by Eastern Cooperative Oncology Group (ECOG).
7. Expected to survive for 3 months or longer after starting administration of the investigational drug.

Exclusion Criteria

1. Females who are pregnant or breastfeeding.
2. Brain metastases with clinical symptoms or which requires treatment.
3. Serious complications or disease history.
4. Subjects who cannot take oral medication.
5. Using antiplatelet/anticoagulant drugs.
6. Continuous using of drugs or foods that strongly inhibit or induce CYP3A4/5 or CYP2D6 during the study period.
7. Scheduled for surgery during the study period.
8. Known to be HIV, HBV or HCV positive.
9. Suffering from psychotic disorder(s) and/or unstable recurrent affective disorder(s) evident by use of anti-psychotics or have had a suicide attempt(s) within approximately the last 2 years.
10. History of drug or alcohol dependency or abuse within 2 years.
11. Presence of a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors.
12. Received any other investigational product or device within 4 weeks before administration.