cyrilzakka/clinical-trials huggingface dataset:
Postural Stability and Ankle Mobility in Haglund Syndrome

The purpose of the study is to find out the impact of Haglund syndrome on ankle plantarflexion and dorsiflexion ROM, dynamic postural stability and fall risk.

This study will be delimited to:

* Total sample size is fifty participants, twenty five patient of symptomatic Haglund syndrome of both gender and twenty five healthy volunteers of matched age, sex and body mass index without any musculoskeletal complaints of the lower limbs.
* Biodex balance system will be used to determine postural stability.
* Ankle plantarflexion and dorsiflexion range of motion will be measured using an Electrogoniometer.
* Age of the patients 25-56
* BMI of (18.5 to 24.9)

Participants:

Fifty volunteers from both genders will participate in the study. They will be assigned from outpatient clinic of Faculty of Physical Therapy, Deraya University. They will be interviewed and divided to twenty five patient of Haglund syndrome as (patient group) after being diagnosed and referred by orthopedic surgeon and twenty five Healthy volunteers as (control group) based on the following inclusion and exclusion criteria:

Eligibility Criteria:
Inclusion Criteria:

* For patient group:

  * Patient referred from orthopedic surgeon with diagnoses as Haglund syndrome according to the following signs and symptoms
  * Calcaneal prominence diagnosed on lateral weight bearing radiograph with bony prominence superior to parallel pitch lines or posterior calcaneal angle greater than 75 degrees
  * Pain medially at insertion of tendo-achilles
  * Palpation of hard, bony prominence
  * Pain upon rising out of bed
  * Both unilateral and bilateral cases, and in consideration of dealing with bilateral cases the tested limb will be the most painful limb.
  * Age of 25-56 years
  * Both males and females.
  * BMI of (18.5 to 24.9)

For control group:

Healthy volunteers of matched age, sex and body mass index without any musculoskeletal complaints of the lower limbs and will be included in the control group in this study .

Exclusion Criteria:

* Musculoskeletal disorders except Haglund syndrome
* cognitive disorder, visual impairment that affected their daily living and any further medical condition that would prohibit them from participating safely in the chosen balance measures
* sensory loss at foot or ankle and with a systemic inﬂammatory disease, such as diabetes mellitus, peripheral neuropathy, rheumatoid arthritis and ankylosing spondylitis, who had undergone corticosteroid injections or physical therapy in the last three months
* Patients with vestibular or neurological disorders
* Any other cause of posterior heel pain.
The Effect of Early Skin-to-skin Contact on Initiation of Breastfeeding, Newborn Temperature and Duration of Third Stage of Labor

Background: Keeping mother and newborn skin-to-skin contact (SSC) after birth brings about numerous protective effects; however, it is an intervention that is underutilized in Iraq where a globally considerable rate of maternal and child death has been reported. The present study was carried out in order to assess the effects of mother and newborn skin-to-skin contact on initiation of breastfeeding, newborn temperature, and duration of the third stage of labor.

Methods: A quasi-experimental study was conducted on 108 healthy women and their neonates (56 in the intervention group with mother and newborn skin-to-skin contact and 52 in the control group that were provided with routine postpartum care) at maternity teaching hospital of Erbil, Iraq from February to May, 2017. The required data were collected using four instruments. The first instrument was a structured interview to elicit socio-demographic and obstetric characteristics from the participants. The second instrument was a form that was used to assess the duration of the third stage of labor in mothers. The third instrument was a form to record the newborns' axillary temperature. The fourth instrument was the LATCH scale that was employed to assess the success of the first breastfeed.Descriptive relationships between demographic variables and type of care provided for mothers and newborns after birth were explored using means and SD for continuous variables, whilst categorical variables were described using proportions. The relationship between SSC and time to initiate breastfeeding, duration of third stage of labour, success of breastfeeding, newborn hypothermia, and temperature of the newborn 30 minutes after birth were examined using T test and Chi square. In logistic regression model, the effect of SSC and conventional care on outcomes of the study was analysed by adjusting of potential confounders like mother's age, education level, occupation, number of parity, and newborn gender.


Eligibility Criteria:
Inclusion Criteria:

* healthy women with term singleton pregnancy

Exclusion Criteria:

* low APGAR score in Newborn
IORT (Intra-operative Radiation Therapy) in Early Stage Breast Cancer

The purpose of this study is to evaluate an investigational way to provide radiation therapy to treat breast cancer at the time of surgery.

Traditionally, the recommended treatment for early stage breast cancer is surgery to remove the tumor, followed by whole breast radiation therapy to decrease the chance of recurrence of the cancer. Whole breast radiation involves daily radiation treatments for 4-6 weeks and can be associated with damage to other tissues including the skin. Recent technological advances have made it possible to provide radiation treatment during the breast cancer surgical procedure. This procedure is called intraoperative radiation therapy (IORT). The University of Virginia has a unique IORT system which allows for the inclusion of cutting edge imaging technology into the IORT procedure in order to provide delivery of radiation directly to the needed areas and to avoid radiation to other tissues.


Eligibility Criteria:
Inclusion Criteria:

* Women 50 years of age of older
* Patient has elected breast conserving surgical treatment for early-stage breast cancer
* Patient meets American Society for Therapeutic Radiation Oncology (ASTRO) criteria for a "suitable" or "cautionary" patient
* Life expectancy of more than 2 years
* Tumor size 4cm or less
* Women of childbearing potential must agree to use adequate contraception

Exclusion Criteria:

* Male
* Pregnant or nursing
* Any contraindication to radiotherapy
* Breast cancer that involves skin or chest wall, bilateral breast cancer or history of breast cancer in ipsilateral breast
* Patient meets any of the ASTRO criteria for an "unsuitable" patient
* Patient requires chemotherapy within two weeks of IORT
* Breast implants
* A serious uncontrolled medical disorder
* Significant history of uncontrolled cardiac disease or CNS disease
Patients Decision Making in Choosing Between Colonic Investigation Alternatives

This is a qualitative interview study to understand patients' priorities for different aspects of tests when considering a colonic investigation. Patients currently waiting for colon capsule endoscopy (CCE), and colonoscopy will be invited to take part. Semi-structured interviews will be carried out over the telephone following an interview guide. Recorded interviews will be transcribed and undergo thematic analysis. We will seek to publish the results of this study to inform future research and developments for colonic investigations.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 who are on the waiting list for a colonoscopy or CCE. Only patients who can provide valid consent will be included.
* English language speaking (translation services are not available for this study).

Exclusion Criteria:

* Patients undergoing colonoscopy due to positive bowel screening test or due to surveillance of known colonic pathology.
Pharmacological Interaction Between Pindolol and MDMA (3,4-Methylenedioxymethamphetamine)

MDMA (3,4-Methylenedioxymethamphetamine, "Ecstasy") produces tachycardia, hypertension, hyperthermia, and other acute adverse effects. Ecstasy use has also been associated with rare cardio- and cerebrovascular complications. The role of beta-blockers in the treatment of cardiovascular and adverse effects of MDMA is unknown.

We investigated the interactive effects of the beta-blocker pindolol (20 mg) with MDMA (1.6 mg/kg) on heart rate, blood pressure, body temperature, and adverse effects in a double-blind placebo-controlled study in 16 healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

* Sufficient understanding of the German language
* Subjects understand the procedures and the risks associated with the study
* Participants must be willing to adhere to the protocol and sign the consent form
* Participants must be willing to refrain from taking illicit psychoactive substances during the study.
* Participants must be willing to drink only alcohol-free liquids and no xanthine-containing liquids after midnight of the evening before the study session.
* Participants must be willing not to drive a traffic vehicle in the evening of the study day.
* Body mass index: 18-25 kg/m2

Exclusion Criteria:

* Chronic or acute medical condition including clinically relevant abnormality in physical exam, laboratory values, or ECG. In particular: Hypertension (\>140/90 mmHg). Personal or first-grade history of seizures. Cardiac or neurological disorder.
* Current or previous psychotic or affective disorder
* Psychotic or affective disorder in first-degree relatives
* Prior illicit drug use (except THC-containing products) more than 5 times or any time within the previous 2 months.
* Participation in another clinical trial (currently or within the last 30 days)
* Use of medications that are contraindicated or otherwise interfere with the effects of the study medications.
A Clinical Trial of Cytotoxic T Cells Augmenting Autologous Hematopoietic Stem Cell (AHSC) Transplantation for Acute Myeloid Leukemia (AML)

The aim of this protocol is to investigate a novel form of immune therapy for patients with acute myelogenous leukemia (AML) who are in remission (CR) but who are at high risk for relapse.

Primary Aim: To conduct a Phase 1/2 clinical trial of autologous CTL-mediated immunotherapy in a homogeneous group of patients with AML who have recently received an autologous hematopoietic stem cell transplant. Specifically:

Phase 1: To determine the MTD of autologous AML-reactive cultured CTL in patients with AML who have recently received an AHSCT.

Phase 2: To determine 1 year progression-free survival of the study group vs institutional historical control group composed of a sequential series of recent patients who have received an AHSCT for AML.

Eligibility Criteria:
Inclusion Criteria (Initial Eligibility Screen):

* Diagnosis of AML, not M3
* At least 10% of circulating leukocytes are AML blast cells
* Age 18 through 75
* Sex male or female
* Patient is considered a potential candidate for AHSCT

Exclusion criteria (Initial Eligibility Screen):

* Participation in another immunotherapy trial within 30 days
* Presence of active malignancy other than AML
* History of autoimmune disease requiring systemic treatment
* ECOG performance status of 3 or 4
* Major organ system dysfunction
* Recent (30 days) or current use of steroids other than topical skin preparations
* History of allogeneic transplant
* Patients who, for any reason are not deemed candidates for AHSCT

Eligibility for autologous CTL Infusion:

Inclusion Criteria:

* Patient has CTL that are in sufficient number and are suitable for infusion
* Patient is stable, afebrile, engrafted, ECOG status 0-2, in CR and received AHSCT 45 - 60 days earlier.

Exclusion or delay criteria:

* Temperature \> 38 C and/or known to be infected
* Absence of engraftment ANC \> 500 and Plt \> 20,000 unsupported
* Life expectancy less than 6 weeks
* Autoimmune disease requiring systemic treatment.
* ECOG performance status of 3 or 4
* Major organ system dysfunction
Retroseptal Transconjunctival Blepharoplasty for GIR

The tear trough deformity is a challenging cosmetic condition.surgical treatment and filling are good treatment options

Procedure is lower eyelid transconjunctival Blepharoplasty associated with stromal vascular fraction gel (SVF-gel) or fat transposition

Eligibility Criteria:
Inclusion Criteria:

* tear trough deformity

Exclusion Criteria:

* Eyelid diseases and previous eyelid surgery
ICU Cell Saver to Reduce Blood Transfusions in Cardiac

PURPOSE: Autotransfusion devices may be employed in cardiac surgery to decrease allogenic blood requirements. Limitations of previous trials include the use of cell saver systems in selected high risk patients only or the lack of blood transfusion-sparing strategies. The aim of this prospective randomized study is to evaluate the efficacy of cell salvage CardioPAT routinely used in cardiac surgery.

METHODS: The investigators will randomize 350 patients in two groups: group 1 receives a CardioPAT cell saver device (175 patients), group 2 doesn't receive any cell saver device. The incidence of allogenic blood transfusion and clinical outcome in both groups are evaluated.


Eligibility Criteria:
Inclusion Criteria:

* All patients presenting for cardiac Surgery

Exclusion Criteria:

* None
Pinpointing the Factors Affecting Clinical Trial Experiences of Glioblastoma Patients

Historically, clinical study participation has been biased toward certain demographics. However, there is a shortage of studies that delve into the underlying factors that influence patient participation, both positively and negatively.

Several people will be invited to enroll in this study so that it may collect a variety of data about glioblastoma clinical trial experiences and identify barriers to participation as well as the causes of participants' failure or withdrawal.

The data collected from this study will be analyzed and used to improve the experiences of future glioblastoma patients who are recruited for medical trials.


Eligibility Criteria:
Inclusion Criteria:

* Patient has self-identified as planning to enroll in a clinical trial
* Patient has been diagnosed with glioblastoma
* Patient is a minimum of 18 years or older

Exclusion Criteria:

* Patient does not understand, sign, and return consent form
* Inability to perform regular electronic reporting
* Patient is pregnant
Falcon Real World Evidence Registry

This is a multi-site registry of patients receiving the Exact Sciences Multicancer Early Detection (MCED) test.

This study was designed to simulate a real-world application of Exact Science's Multicancer Early Detection (MCED) test. Participants will be offered the Exact Science's MCED test annually for 3 years. If at any point during those 3 years a participant is diagnosed with cancer, they will become ineligible for further testing. Data will be collected for 5 years following the baseline test.

There will be two data collection approaches as part of this study. The first will be collection of self-report data related to the testing experience. The second will be periodic and largely automated extraction of pre-specified data elements from existing electronic data sources. A comparison data set will be constructed from records of individuals who did not receive the MCED test.

Eligibility Criteria:
Inclusion Criteria:

* Participant age at time of consent is between 50 and 80 years
* Agree to receive the Exact Sciences MCED test and follow-up imaging
* Willing and able to provide informed consent
* Access to a suitable technology and willing to complete surveys electronically

Exclusion Criteria:

* Any invasive tumor (excluding non-melanoma skin cancers) or hematological malignancy in the previous three years or current suspicion of cancer and/or in active treatment (e.g., chemotherapy, radiation therapy, immunotherapy, and/or surgery
Novel and Scalable Internet Supplemented Weight Loss Treatment in Primary Care

Motivational interviewing and nutritional counseling for weight loss in primary care.

Overweight and obese participants will be recruited through local primary care offices. This study will test the effectiveness of motivational interviewing and nutritional counseling for weight loss. The treatment will be supplemented by internet support.

Eligibility Criteria:
Inclusion Criteria:

* BMI 25-55
* Daily access to internet and phone
* Recruited through local primary care offices.
* Age 18-65

Exclusion Criteria:

* Co-existing physical and/or psychiatric conditions that require more significant treatment (e.g., bipolar disorder, psychotic illnesses), and/or require more intensive treatment or hospitalization (e.g., suicidality, severe mood disorders)
* Meets criteria for current substance abuse/dependence
* Currently receiving psychiatric, psychological, behavioral, or pharmacologic treatment that is known to affect weight or eating
* Pregnant, breastfeeding, or plans to become pregnant during the treatment period
* Cardiac disease, including ischemic heart disease, congestive heart failure, conduction abnormalities, or a history of heart attack
* Serious neurologic illnesses (e.g., seizure history) or medical illnesses (e.g., impaired hepatic or renal function)
* Uncontrolled diabetes, thyroid conditions, or hypertension
Infiltrations of OnaBotulinum Toxin A in Resistant Depression: Comparison of Two Facial Injection Sites.

The aim of the study is to evaluate in adult subjects with resistant depression the effect of an injection of botulinum toxin in the corrugator and procerus muscles, in comparison to the infiltration of the crow's feet area, in addition to the current antidepressant treatment.

Three randomized, double-blind, placebo-controlled studies have shown that a single injection of OnaBotulinum Toxin A (OnaA) into the corrugator and procerus (frowning muscles) allows for a significant decrease in patients with a depressive episode characterized resistant.

However, the effectiveness of this method of treating depression can not currently be considered established.

The main objective of our study is therefore to evaluate the efficacy of OnaA injections in the glabellar zone with a different methodology, using lateral muscle injection orbicularis oculi (involved in crow's feet wrinkles). ) as another injection zone in comparison.

The efficacy will correspond to the number of responders at 6 weeks in the two groups of injection.

This evaluation will be done at 6 weeks, then at 3 months (S12).

Eligibility Criteria:
Inclusion Criteria:

* Male or female from 18 to 80 years old included
* Inpatient or ambulatory patients treated for resistant depressive episode, that is to say by an absence of symptomatic remission (nonresponse or partial response) after the use of two successive trials of antidepressants of different pharmacological class, well conducted in terms of dosage and duration, while ensuring quality adherence (at least 80% of the treatment taken during the period considered)
* Diagnosis according to DSM-5 depressive episode characterized with MADRS score\> 20
* Women of childbearing potential must have an effective method of contraception (failure rate \<1% per year with correct use): IUD, pill, ... (participant statement)
* Patient able to adhere to the restrictions and prohibitions of the protocol
* Patient agreeing to sign an informed consent

Exclusion Criteria:

* Current psychiatric comorbidity
* Severe intellectual disability
* Known hypersensitivity to botulinum toxin type A or any of the excipients
* Myasthenia gravis
* Presence of infection at the injection site (s)
* Participation in an interventional clinical study.
* Pregnant woman, breastfeeding, or who plans to be pregnant during the study or within 6 weeks after the last administration of the treatment.
* Any patient already receiving aesthetic treatment
Study of BOTOX Injections to Assess Change in Disease Symptoms in Adult Participants With Upper Limb Essential Tremor

Upper limb essential tremor (UL ET) is a movement disorder characterized by postural and/or kinetic tremor. It can cause difficulty with everyday tasks such as writing, pouring, and eating, and patients also experience associated social embarrassment. This study will assess how safe and effective BOTOX is in treating UL ET. Adverse events and change in disease activity will be evaluated.

BOTOX is an investigational drug being developed for the treatment of UL ET. Participants are randomly assigned to 1 of the 4 groups, called treatment arms. Each group receives different treatment. There is 1 in 2 chance that participants will be assigned to placebo. Around 174 participants, aged 18 to 80 years with UL ET will be enrolled in approximately 40 sites in North America.

Participants will receive BOTOX or placebo injections in Cycle 1 and Cycle 2. In Cycle 3, participants will receive unilateral or bilateral BOTOX injections. Each cycle is 12 weeks.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of essential tremor in accordance with modified Tremor Investigation Group (TRIG) criteria as described in the protocol.
* TREDS-Revised Scale (1-4 scale, whole numbers) unilateral score of \>= 3 for the Tremor Disability Scale (TREDS) on any of the 7 unilateral items; no more than a single item score of 1 among the 7 unilateral items in the dominant limb.
* TETRAS activities of daily living (ADL) (recorded on a 0-4 scale, whole numbers) minimum score of \>= 3 on any of the 5 unilateral items; no more than a single item score of \<=1 among the 5 unilateral items in the dominant limb.
* At least one of the following criteria must also be met:

  * TETRAS UL score (0-4 scale, with 0.5 increments) of \> 2 in the dominant limb on at least one of the 3 maneuvers OR
  * TETRAS Archimedes spiral task score (0-4 scale, with 0.5 increments) of \> 2 in the dominant limb

Exclusion Criteria:

* Any uncontrolled clinically significant medical condition other than the one under study.
* Any medical condition that may put the participant at increased risk with exposure to BOTOX Purified Neurotoxin Complex.
SWOG-9245 Collecting and Storing Tissue Samples From Patients With Relapsed or Recurrent Non-Hodgkin Lymphoma After Treatment on a Southwest Oncology Group Clinical Trial

RATIONALE: Collecting and storing samples of tissue from patients with non-Hodgkin lymphoma to study in the laboratory may help the study of cancer in the future.

PURPOSE: This laboratory study is collecting and storing tissue samples from patients with relapsed or recurrent non-Hodgkin lymphoma after treatment on a Southwest Oncology Group (SWOG) clinical trial.

OBJECTIVES:

* Acquire fresh snap-frozen lymphoma tissue from patients with relapsed or recurrent non-Hodgkin lymphoma after treatment on a Southwest Oncology Group (SWOG) clinical trial.
* Establish a standard set of procedures for routine acquisition, banking, and study of lymphoma tissues within the SWOG.
* Use repository tissue to establish clinical correlations via presently activated phenotyping studies and future projected molecular studies assessing specimen DNA and RNA status.
* Examine the biology of therapy failure in relationship to changes in pretreatment and post-treatment immunophenotypic data.

OUTLINE: This is a multicenter study.

Tissues collected at biopsy are snap-frozen and archived for future molecular and genetic studies.

PROJECTED ACCRUAL: Not specified

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of relapsed or recurrent non-Hodgkin lymphoma (NHL)
* Previously registered on 1 of the following SWOG clinical trials for previously untreated NHL:

  * SWOG-8410
  * SWOG-8503
  * SWOG-8508
  * SWOG-8516
  * SWOG-8736
  * SWOG-8809
  * SWOG-8907
  * SWOG-8954
  * SWOG-9125
  * SWOG-9240
  * SWOG-9320
  * SWOG-9349
  * SWOG-9432
  * SWOG-9501
  * SWOG-9703
  * SWOG-S9704
  * SWOG-9800
* Tissue samples of relapsed or recurrent disease available

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics