cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Nitrogen Mustard in Treatment of Mycosis Fungoides

This study will evaluate the efficacy, tolerability and safety of the topical application of mechlorethamine (MCH) formulations in patients with stage I or IIA mycosis fungoides (MF).

The successful use of mechlorethamine (MCH) as a topical agent in the treatment of mycosis fungoides, a form of cutaneous T-cell lymphoma, was first reported in the late 1950s, and provided a rationale for skin-directed chemotherapy that minimized systemic toxicity. Since then, multiple investigators have demonstrated the safety and efficacy of topically applied MCH in the treatment of mycosis fungoides. This study will evaluate the efficacy (non-inferiority), tolerability and safety of topical application of MCH proprietary gel versus a compounded ointment formulation in Aquaphor in patients with stage I or IIA MF.

Eligibility Criteria:
Inclusion Criteria:

* Patients with mycosis fungoides confirmed by a skin biopsy
* Stage I or IIA patients must have been treated previously with prior topical therapies including PUVA, UVB, topical steroids, but not NM within the past 2 years, or topical carmustine (BCNU)
* Patients must be otherwise healthy with acceptable organ function.
* Prior to initiating study therapy, patients must not have had topical therapy within four weeks
* Lab values within normal range
* Willing/able to give consent
* Must use effective means of contraception if of childbearing potential

Exclusion Criteria:

* Newly diagnosed mycosis fungoides with no prior therapy
* A prior history of treatment with topical NM within the past 2 years or topical carmustine (BCNU)
* Use of topical or systemic therapies for MF within four (4) weeks of entry in the study
* Patients with a diagnosis of stage IIB-IV MF
* Serious known concurrent medical illness or infection, which could potentially present a safety risk and/or prevent compliance with the requirements of the treatment program
* Pregnant or nursing females, or males and females of childbearing potential, not using an effective means of contraception
* Patients who have had radiation therapy within one year of study start
* Patients who have a history of a higher T score than T2 or a higher N score than N1
* Patients who do not agree to do all labs at one site
Atrificial Shrinkage of Blastocyst Before In Vitro Fertilization

Vitrification is a modern cryopreservation technique based on sudden cooling of reproductive cells to a temperature of -196 ° C in seconds that produces glass-like solidification of a solution without crystallization, but by extreme elevation in viscosity during freezing

Vitrification is a modern cryopreservation technique based on sudden cooling of reproductive cells to a temperature of -196 ° C in seconds that produces glass-like solidification of a solution without crystallization, but by extreme elevation in viscosity during freezing Unlike the slow freezing method, vitrification has better results in a complete elimination of ice crystal inside the cells as well as in the surrounding solution -Also, it has a significantly higher post-thawing survival rate in comparison to slow freezing method

Eligibility Criteria:
Inclusion Criteria:

* women with infertility from 20 to 44 years

Exclusion Criteria:

* women with age more than 44 or less than 20
Lavender Aromatherapy for Sleep in Hospitalized Adult Patients

This feasibility study's aim is to determine the effectiveness of lavender oil aromatherapy on quality and duration of sleep in hospitalized adult patients

Hospitalized patients on a medical unit will be randomly assigned to one of three groups of 36 patients: Intervention (Lavender oil), Placebo Intervention (Grapeseed Oil), or Control (Standard of Care). Following a determination of meeting inclusion criteria on admission and completing informed consent, subjects will be randomized to one of three groups on admission. This is a 4 day study with pre- intervention (baseline) sleep data on quality and duration of sleep using the Verrans \& Halpern- Snyder Sleep Scale collected on Day 2, following admission day.

For the intervention, indirect aromatherapy, a 2x2 gauze with 2 drops of either oil (lavender or grapeseed is pinned it to the subjects' nightgown (right scapula area) for two sequential nights (Time 1 and Time 2) (Day 2 and 3) and removed in the morning after 10 hours . Sleep Quality and Duration are then measured in the morning, Time 1 and Time 2, (Day 3 and Day 4) by the Verran \& Snyder-Halpern Sleep Scale analogue. The control group receives standard of care in the evenings and the same data as the intervention groups are collected for sleep quality and duration, pre-intervention and Time 1 and Time 2 ..

The differences in the scores for sleep quality and duration will be compared from pre-intervention to Time 1 and Time 2 for each group .

Eligibility Criteria:
Inclusion Criteria

* Ability to speak, read and understand English.
* Ability to use an electronic "pad" following instruction and assistance for data collection

Exclusion Criteria:

* Cognitive impairment .Allergy to lavender or grapeseed oil
* .Any condition that has been reported to affect the sense of smell
* Newly prescribed sleep medications (last two weeks prior to admission) or those causing sleepiness
* Pregnancy
* Currently using lavender therapy (aroma, massage, etc.).
* A smoker of any kind (tobacco, electronic cigarettes) .
* History of migraine headaches.
* Asthma, Bronchitis, or any airway disease.
Proximal Strengthening for the Management of Wrist Pain

This study will be a randomized controlled trial comparing proximal strengthening vs. traditional hand therapy for patients with wrist pain. Patients will attend 2 hand therapy sessions per week for 4 weeks. Change in patient function and pain as measured by the patient rated wrist evaluation will be the primary outcome of interest

This will be a non-blinded randomized controlled trial using a sample of consecutive patients with wrist pain. Patients who are referred to Nationwide Children's Hospital Hand therapy clinics with a primary complaint of wrist pain will be considered for this study.

Patients will be randomly assigned to one of two treatment groups; The proximal strengthening group or Traditional Hand Therapy Group. Both treatment groups will be evaluated and treated by the certified hand therapists for 2 sessions per week for 4 weeks. Both groups will receive similar treatment durations of 45-60 minutes per session based on each patient's individual needs.

Proximal strengthening group-The experimental proximal strengthening group consists of treatment where the hand therapist address specific impairments at the wrist and hand for 20-30 minutes at each treatment session. Patients allocated to this treatment group will also perform a standardized proximal strengthening protocol consisting of cervical, periscapular, and shoulder strengthening exercises. Depending on the pace and guidance needed for these exercises 25-30 minutes will be spent on proximal strengthening exercises. As the patients endurance and strength increased the repetitions and/or resistance of these exercises will increase.

Traditional Hand Therapy Group This active comparator group consists of treatment where the hand therapist address specific impairments at the wrist and hand for 45-60 minutes at each treatment session. Treatment can include stretching, motion, and strengthening exercises. As the patients endurance and strength increased the repetitions and/or resistance of these exercises will increase. Modalities for pain control and tissue mobility, and bracing or splinting if necessary. All treatments for the traditional hand therapy treatment group will occur seated at the hand therapy treatment table.

Eligibility Criteria:
Inclusion Criteria:

* Wrist pain

Exclusion Criteria:

* \<8 years of age
* any neurological disorder
* Juvenile rheumatoid arthritis
* juvenile idiopathic arthritis
* Wrist fractures \< 16 weeks from date of injury or surgery
* Tendon repair
* Nerve injury or repair
* Inability to follow directions
* Inability to attend follow-up appointments
Characterize the Regional Distribution of [11C] ABP688 in Brain by Positron Emission Tomography (PET)

This study is designed to characterize the regional distribution of \[11C\] ABP688 in brain by positron emission tomography (PET).


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects 55-80 (inclusive)
* Subjects in good health

At screening:

* oral body temperature between 35-37.5C
* systolic blood pressure: 90-140 mm Hg
* diastolic blood pressure: 50-90 mm Hg
* pulse rate: 40-90 bpm
* Female subjects of child bearing potential must have been using a double-barrier local contraception
* Postmenopausal women must have had no menstrual bleeding
* Subjects must have weighed at least 50 kg
* All subjects must provide informed consent
* All subjects must have been able to communicate well with investigator

Specific to Major depression disorder (MDD)

Patients had to show following level of symptomatology:

* HAM-D (17-item scale) \> 16
* CGI \> 4 (moderately ill)

Exclusion Criteria:

Specific criteria for healthy volunteers:

- Presence and/or history of clinically significant major neurological or psychiatric disorder

Specific criteria for MDD patients:

* Presence and/or history of a clinically significant major neurological or psychiatric disorder other than MDD or generalized anxiety disorder
* Axis I co-morbidity was excluded except anxiety spectrum disorders

Criteria for both:

* Smokers
* Pregnancy
* Subjects with history of or symptoms/complaints consistent with mild cognitive impairment
* Use of any psychotropic prescription drugs
* Coffee consumers more than 6 cups/day
* Participation in any clinical investigation
* Donation or loss of 400 mL or more of blood
* Significant illness within 2 weeks prior to dosing
* A known hypersensitivity to study drug
* MRI scan that showed evidence of stroke
* Any surgical or medical condition which might have significantly altered distribution
* Clinical evidence of any abnormal lab value
* History of immunodeficiency disease
* Positive Hepatitis B surface antigen
* Presence of contraindications to PET scan investigations- Presence of contraindications to MRI investigations
* Evidence from an Allen test of incomplete communication
* History of drug or alcohol abuse
* Current use of anticonvulsant
* Significant radiation exposure

Other protocol-defined inclusion/exclusion criteria may apply.
Evaluation of Green Tea as Antioxidant Agent in Management of Oral Lichen Planus

The study included forty individuals divided into 3 groups. 10 control subjects, 15 oral lichen planus (OLP) patients who were treated with topical corticosteroids and 15 oral lichen planus (OLP) patients who were treated with topical corticosteroids and green tea tablets.

This study included forty individuals divided into 3 groups. Group A; 10 systemically healthy control subjects not receiving medication.

Group B; 15 Patients who were previously diagnosed with OLP presented in acute exacerbation were treated with topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month.

Group C; 15 Patients who were previously diagnosed with OLP presented in acute exacerbation were treated with both topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month in addition to green tea tablets 200 mg (Green tea extract 5:1, El Obour For Modern Pharmaceutical Industries) as one tablet a day also for one month.

Eligibility Criteria:
Inclusion Criteria:

* Patients presented with painful oral lichen planus lesions
* Free of any visible oral lesions other than oral lichen planus
* Free of any systemic diseases

Exclusion Criteria:

* Topical treatment or systemic therapy of OLP for one month before starting the study
* Pregnant or breast feeding women
* Smokers
* Use of corticosteroids or other immunosuppressive drugs
The Study of Olanzapine Plus Fluoxetine in Combination for Treatment of Treatment Resistant Depression

The purposes of this study are to determine:

* Whether olanzapine plus fluoxetine in combination will help patients with treatment-resistant major depression.
* The safety of olanzapine plus fluoxetine in combination, plus and any side effects that might be associated with the combination.
* The effectiveness of olanzapine plus fluoxetine compared to olanzapine and fluoxetine alone.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients, 18 - 65 years of age.
* Each patient must have a level of understanding sufficient to perform all tests and examinations required by the protocol, and must be considered reliable according to the investigator's clinical judgement
* Patients must fulfill the criteria for recurrent MDD without psychotic features as defined by the DSM-IV, based on clinical assessment and confirmed by Structured Clinical Interview for DSM-IV Axis I Disorders - Clinical Version (SCID-I) plus the Major Depressive Disorder Specifiers included in the Research Version of the SCID-I. This includes at least one of the following diagnoses: 296.31, 296.32, and 296.33
* Female patients of childbearing potential must be using a medically accepted means of contraception throughout the course of the study. Use of any oral or injectable contraception must be initiated prior to visit 2
* Failure to achieve satisfactory antidepressant response to an adequate trial of an antidepressant (except fluoxetine), for at least 6 weeks at an acceptable dose or greater, occurring within the current episode of MDD

Exclusion Criteria:

* Treatment with a drug within the last 30 days that has not received regulatory approval at the time of study entry
* Exposure to OFC in a Lilly-sponsored clinical trial investigating OFC, and any patients historically failing to respond to olanzapine and fluoxetine in combination under any circumstance
* Persons who have previously entered any Lilly-sponsored study which was investigating olanzapine
* Female patients who are either pregnant or nursing
* Serious, unstable illnesses for which death is anticipated within 1 year of intensive care unit hospitalization for the disease is anticipated within 6 months. This includes hepatic (specifically any degree of jaundice), renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic diseases (specifically current agranulocytosis with an absolute neutrophil count \< 500 mm_3)
Clinical Study to Evaluate the Efficacy and Safety of GNS-212-E in Bowel Preparation for Colonoscopy

This is a prospective, randomized, single-blind, parallel, active-controlled, and multi-center Phase III clinical trial.


Eligibility Criteria:
Inclusion Criteria:

1. Adult men and women between 19 years and 79 age or older as of the date of consent in writing
2. 19 kg/㎡ ≤ BMI \< 30 kg/㎡
3. a prospective colonoscopy patient
4. For women of childbearing potential, those who agree to use a medically acceptable contraceptive method\* during the clinical trial period

   \*hormonal contraceptive, implantation of intrauterine device or intrauterine system, Infertility procedures/surgery (e.g., bilateral ovarian ligation, vasectomy)
5. A person who voluntarily agrees to participate in this clinical trial and signs a written agreement Abbreviation
6. Women of childbearing potential must have a negative serum or urine pregnancy test before Investigational Product administration

Exclusion Criteria:

1. A person having constipation who is regularly administered laxatives or gastrointestinal motility promoters
2. A person with a history of significant gastrointestinal surgeries, including colonic resection, subtotal colectomy, abdominoperineal resection
3. A person diagnosed with acute coronary disease, arrhythmia, cardiomyopathy, cardiac valvular disease, aortic and peripheral vascular disease
4. Active infection or high fever above 38°C
5. Uncontrolled chronic medical illnesses or suspected symptoms that hinder participation such as major cardiac, renal, and metabolic (ex, Subjects with severe renal disease).
6. Clinically significant abnormal laboratory values of screening.(Creatinine, AST or ALT )
7. Active hepatitis B or hepatitis C with positive HBsAg and HCV Ab tests at screening
8. Positive for Human Immuno-deficiency Virus (HIV) at the time of screening
9. Severe nausea or vomiting
10. Severe abdominal distension or abdominal pain
11. A person prone to aspiration or reflux
12. A person who undergoes colonoscopy for the following therapeutic purpose (1) balloon dilatation of the stenosis area (2) non-toxic giant colon or decompression of the S-phase colitis (sigmoid volvulus) (3) Removal of foreign substances (4) Vascular dysplasia, ulcer, tumor and treatment of bleeding after polypectomy
13. A person who is hypersensitive to the ingredients of a clinical trial drug
14. Pregnant woman or a lactating woman
15. A person who has serious mental disabilities
16. A person who requires the administration of drugs prohibited from concomitant use
17. A person who is administered another investigational drug or has been provided with a clinical trial medical device within 6 months prior to participating in a clinical trial
18. The person whom the investigator determines to be unsuitable for this study
Clinical Study on the Use of Massage to Reconstruct the Function of Lumbar Stabilizer Muscles and Improve the "Muscle and Bone Imbalance" of Lumbar Disc Herniation

1. .Characterization of Stabilizing Muscle Dysfunction in LDH Patients Using advanced techniques such as high-density surface electromyography (HD-sEMG), this study will investigate the functional imbalance of lumbar stabilizing muscles in LDH patients by comparing their muscle function indicators to those of healthy controls.
2. .Impact of Spinal Manipulation on Lumbar Stabilizing Muscle Function Through serial sEMG evaluations, the study will assess changes in stabilizing muscle function in LDH patients before and after spinal manipulation. This includes a focus on endurance, motor control, and reaction time, providing evidence to inform the application of spinal manipulation in LDH treatment.
3. .Exploration of Mechanisms Underlying Spinal Manipulation in Improving "Musculoskeletal Imbalance" The study will examine correlations between improvements in stabilizing muscle function and clinical symptoms, such as pain relief and functional recovery. Statistical analyses of sEMG data and clinical efficacy indicators will be conducted to uncover the therapeutic characteristics of spinal manipulation in LDH intervention, offering new theoretical bases and strategies for long-term treatment and recurrence prevention.


Eligibility Criteria:
Inclusion Criteria:

* 1.Meet the diagnostic criteria for LDH as outlined in the ninth edition of "Surgery," with confirmation via MRI;
* 2.Age between 20 and 50;
* 3.Simple L4/5 disc herniation; VAS score ≥30/100;
* 4.Lumbar ODI index ≥20;
* 5.No massage, acupuncture, or physical therapy within the past month;
* 6.Signed informed consent form.

Exclusion Criteria:

* 1: Exclusion criteria: history of spinal surgery or severe spinal trauma;
* 2: combined with bone tuberculosis, tumors, severe osteoporosis, etc;
* 3: combined with serious internal diseases such as cardiovascular, hematological, digestive system diseases, or psychiatric disorders;
* 4: pregnant or lactating women;
* 5: combined with autoimmune diseases, allergic diseases, acute or chronic infectious diseases accompanied by pain and joint dysfunction;
* 6: MRI showing free nucleus pulposus or accompanied by cauda equina syndrome.
Investigation of Inspiratory Muscle Strength and Cardiorespiratory Fitness in Sarcopenic Individuals

The aim of our study is to examine the effects of sarcopenia and dynapenia on inspiratory muscle strength and cardiorespiratory fitness in geriatric individuals.

Within the scope of the study, anterior thigh thicknesses of geriatric individuals will be evaluated by ultrasonography and individuals will be divided into 3 groups as dynapenic, sarcopenic and normal according to the ISarcoPRM algorithm, using the STAR method and Hand-grip. The Powerbreathe K5 device will be used to evaluate the inspiratory muscle strength of geriatric individuals in both groups, and the 2-minute step test will be used to evaluate cardiorespiratory fitness. The study will be carried out with 100 geriatric individuals. As a result of the study, first the inspiratory muscle strength and cardiorespiratory fitness of sarcopenic, dynapenic and non-sarcopenic groups will be compared. Afterwards, the relationship between anterior thigh thickness and inspiratory muscle strength of all geriatric individuals participating in the study will be examined.

Eligibility Criteria:
Inclusion Criteria:

* Getting a score between 24 and 30 on the Mini Mental State Assessment
* Ability to stand without assistance for at least 90 seconds

Exclusion Criteria:

* Inability to communicate verbally
* Using a walking aid
* Older adults with severe visual impairment, neurological disorders, and/or congestive heart failure
* Older adults for whom exercise is not recommended
Intensive Pharmacovigilance Program for Elaprase (SHP ELA-701)

The purpose of this non-interventional, observational study which is conducted in Mexico is to evaluate the safety profile of elaprase (idulsurfase) in participants with hunter syndrome (mucopolysaccharydosis II) being treated with elaprase.


Eligibility Criteria:
Inclusion Criteria:

* Participants of both genders
* Participants to whom idursulfase (Elaprase) has been prescribed
* Participants with Hunter syndrome
* Participants accepting to participate
* Participants signing the informed consent and privacy notice for handling personal information in: the program Contigo Shire (training, diagnosis, family trees) and the intensive pharmacovigilance study for Elaprase. If the participant is unable to provide legal consent (example: under legal age), the participant's legal guardian must provide consent

Exclusion Criteria:

* Participants withdrawing their consent to continue participating in the non-intervention intensive pharmacovigilance study for Elaprase
* Known hypersensitivity or presence of any contraindication to Elaprase that cannot be controlled by pre-medication
* A physical condition that would not permit intravenous administration of enzyme replacement therapy (ERT)
* Participants enrolled in Shire sponsored Elaprase Registry or any other Shire sponsored Elaprase study