cyrilzakka/clinical-trials huggingface dataset:
Comparison Of Spencer Technique And Isotonic Exercise In Patients With Adhesive Capsulitis

This study examines the efficacy of two forms of therapy for Adhesive Capsulitis, a condition characterized by stiffness, pain, and limited mobility in the shoulder joint. It is also commonly known as "Frozen Shoulder".

Patients between the ages of 30 and 55 were randomly assigned to one of two groups for the trial held at the Saleem Free Hospital Okara and Dar-ul-Shifa Hospital. Group 2 engaged in isotonic exercises that emphasized concentric and eccentric motions of forward flexion and extension, whereas Group 1 was given the Spencer approach, which involved seven different movements. A goniometer and the Numeric Pain Rating Scale were used to measure the range of motion and pain. SPSS 20 was used to analyze the data and assess how well the treatments worked. The findings provided light on how well manual therapy and exercise compare in terms of reducing pain and increasing shoulder movement in people with adhesive capsulitis.

Eligibility Criteria:
Inclusion Criteria

* Both genders aged 30-55 years
* Unilateral Adhesive Capsulitis
* Pain lasting for more than one month
* Capsular pattern of motion restriction
* Diabetic patients were included.

Exclusion Criteria

* Participants with rotator cuff tear
* Rheumatoid and gouty arthritis
* Tumors of the shoulder region
* Peripheral nerve injuries
* Shoulder girdle fracture and dislocation
* History of shoulder surgery were excluded.
Efficacy of 17 Alpha-hydroxyprogesterones Caproate for the Prevention of Preterm Delivery

To demonstrate that the intramuscular administration of 17 alpha hydroxyprogesterones caproate allows to reduce the risk of preterm delivery, in 3 high risk populations defined by the association of an ultrasonographic cervical length egal and inferiority 26 mm between 20 and 32 weeks of gestation and:

* either a first episode of preterm labor stopped by acute tocolysis;
* either a history of late miscarriage or premature delivery or uterine malformation or DES
* either a twin pregnancy. Therefore, a randomised, multicentre trial has been designed with initial stratification according to these three risk groups, opened with two parallel arms.

Objective

To demonstrate that the intramuscular administration of 17 alpha - hydroxyprogesterones caproate allows to reduce the risk of preterm delivery, in 3 high risk populations defined by the association of an ultrasonographic cervical length 26 mm between 20 and 32 weeks of gestation and:

* either a first episode of preterm labor stopped by acute tocolysis;
* either a history of late miscarriage or premature delivery or uterine malformation or DES
* either a twin pregnancy. Experimental design Prospective, randomized, multicenter, trial with initial stratification according to three risk groups, opened with two parallel arms.

The maximal duration for treatment will be 16 weeks for each included patient. The duration for inclusions will be 30 months. The duration for participation of each patient will be 10 to 22 weeks. The foreseen inclusion period for this trial is from 06/01/2006 to 12/31/2008 Description Two therapeutic strategies will be compared in each risk group and attributed by uniform randomisation.

Arm A :IM injection of 17 alpha hydroxyprogesterones caproate, 500 mg, twice a week until 36 W or until preterm delivery in high risk symptomatic group and high risk twin pregnancies group.

IM injection of 17 alpha-hydroxyprogesterones caproate, 500 mg, once a week until 36 W or until preterm delivery in high risk asymptomatic group.

Arm B :No treatment with 17 alpha-hydroxyprogesterones caproate. (usual management) Presentation : Progesterone retard Pharlon 500 mg Tolerance criteria

* nausea,vomiting,
* weakness

Eligibility Criteria:
Inclusion Criteria:

* ultrasonographic cervical length 26 mm between 20 and 32 weeks of gestation and:
* either a first episode of preterm labor stopped by acute tocolysis
* either a history of late miscarriage or premature delivery or uterine malformation or DES;
* either a twin pregnancy.

Exclusion Criteria:

* cervical dilatation \> 3 cm,
* chorioamnionitis,
* fetal distress,
* placenta praevia,
* abruptio placenta,
* preterm premature rupture of membranes,
* polyhydramnios,
* Twin-twin transfusion syndrome,
* IUGR,
* preeclampsia or hypertension,
* other pathology justifying a preterm delivery,
* epilepsy drugs
* participation to another therapeutic trial,
* any patient for whom informed consent cannot be obtained.
Th Effects of a Drug Dexmedotemidine in Regional Anesthesia in Participants Undergoing Upper Limb Surgeries

In this study, we will assess the effect of combined Dexmedetomidine and Bupivacaine analgesia on the onset and duration of anesthesia in supraclavicular plexus block compared to Bupivacaine alone.

Participants who fulfill the inclusion criteria will be enrolled in this study to achieve sample size of 140 participants, 70 participants in each group.

Participants were blindly randomized into two groups: group A (Bupivacaine alone) and group B (Bupivacaine with Dexmedetomidine).

On the morning of the surgery day, and before performing the procedure on the targeted hand, a venous cannula 18gauze was secured on the opposite hand. Routine monitors like pulse oximetry, non-invasive blood pressure, and electrocardiogram were attached during the procedure.

Study medications were prepared for each group, which is Bupivacaine (30ml) only for group A and Bupivacaine (30 ml) with Dexmedetomidine (1 mcg /kg) for group B. Then, SCPB was done under ultrasound guidance which increases the safety due to improved monitoring of anatomy and needle placement. A needle was placed within the brachial plexus sheath posterior to the subclavian artery, and the local anesthetic injected to surround the trunks and divisions of the brachial plexus at this level.

Patients were evaluated for the onset of the sensory and motor block every 3 minutes after completion of injection till their onset, and, at 15, 30, 45, 60, 90, and 120 min; and then hourly (even after surgery), until they had resolved.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18-75 years.
* Classified as grades 1 or 2 by the American Society of Anesthesiology Classification of .physical status.
* Willing and able to sign a consent form.

Exclusion Criteria:

* Patients under the following conditions will be excluded: Known hypersensitivity to Bupivacaine, Dexmedetomidine, and local anesthetics.
* Uncontrolled diabetes mellitus.
* Peripheral neuropathy.
* SevereCoagulopathy.
* Infection at the site of block.
* Pregnancy.
* Cardiac arrhythmias.
* Prescription of beta blockers.
* Psychological disorders.
Fitostimoline® Hydrogel Versus Saline Gauze Dressing in Diabetic Foot Ulcers

Diabetes Mellitus (DM) is one of the most widespread metabolic diseases and the alarming rise in its prevalence worldwide poses enormous challenges. The microvascular and macrovascular complications of DM heavy impact on longevity and quality of life, and in particular diabetic foot ulcers (DFUs) are among the ten top causes of worldwide disease burden and disability Essential components of the standard care, management, and treatment of DFUs are represented by health education, strict control of blood glucose and cardiovascular risk factors, offloading, local debridement, and adequate dressing. A wide variety of dressing is available, and these include basic contact dressings (low adherence dressings such as saline gauze, paraffin gauze or simple absorbent dressings) and advanced dressings (alginate, hydrogel, films, hydrocolloid, foam).

It is important underline that due to lack of evidence from head-to-head randomized controlled trials (RCTs), the relative effects of any of these dressings in DFUs remain unclear. Consequently, so far clinical evidence supporting the choice for either hydrogel or saline gauze dressing, has been related mostly on clinician perception rather than high quality evidence. Here we evaluated the efficacy and safety of Fitostimoline® hydrogel dressing versus saline gauze dressing in patients with DFUs in a monocentric, two-arm, open-label, randomized, controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes and type 2 diabetes,
* adult patients with DFUs at Grades IC or IIC for a period of at least 12 weeks,
* an akle brachial index \>0.8,
* be able to understand simple instructions,
* provided voluntary, signed informed consent

Exclusion Criteria:

* active infection
* evidence of ischaemia in the limb,
* osteomyelitis,
* gangrene,
* systemic inflammatory or autoimmune disease,
* use of corticosteroids, immunosuppressive agents, radiation therapy and chemotherapyan,
* known hypersensitivity to any of the dressing components.
Comparison of Outcome Parameters in Laser Rhytide Treatment

We previously published a comparative split-face study which has shown a significant, albeit moderate, effect of ablative fractional laser treatment. While indicating that a single session with fractional ablative lasers can be effective in the treatment of peri-orbital wrinkles, the trial also revealed substantial disagreement between the different end points (profilometry, Fitzpatrick wrinkle score, patient satisfaction). Since the PBI is a patient-related index it could not be included in the aforementioned split-face trial; the present study therefore attempts to further elucidate the patient-related benefit of a single fractional ablative laser treatment session as well as carefully analyse the respective correlations between the outcome parameters employed.


Eligibility Criteria:
Inclusion Criteria:

* mild to moderate peri-orbital rhytides ('crow's feet') at rest (Class II according to Fitzpatrick)

Exclusion Criteria:

* unrealistic expectations
* inability to meet follow-up criteria
* Fitzpatrick skin phototype \>III
* coagulation disorders or anti-coagulant treatment
* allergy to lidocaine or tetracaine
* oral isotretinoin within the last 6 months
* any active skin disease within the treatment areas (e.g., psoriasis, cancer, or autoimmune disease)
* synthetic implants in the treatment area
* facial cosmetic procedures affecting the treatment area within the last 6 months
* photosensitizing medications (e.g., tetracycline, gold)
* history of keloid formation
* pregnancy
Tolerability of Device Based Therapies for Neurofibromatosis Type 1 Cutaneous Neurofibromas

This study will evaluate the tolerability and effectiveness of three FDA-approved treatments in Neurofibromatosis Type 1 Cutaneous Neurofibromas. These treatments are: a 1064nm laser, a 755nm laser, and a Kybella injection. Each patient will have a treatment and a control site.


Eligibility Criteria:
Inclusion Criteria:

* Adult males and females ≥18 years of age
* Have a diagnosis of Neurofibromatosis Type 1
* Patients must be seeking treatment for cutaneous Neurofibromas
* Patients must have ≥ 6 paired cutaneous Neurofibromas (3 to be treated and 3 untreated) that are visible and measure between 2-4mm in size.
* Able and willing to comply with all visit, treatment and evaluation schedules and requirements
* Able to understand and provide written informed consent
* Access to a Smart Phone to be able to take and upload photographs to an application

Exclusion Criteria:

* Patients who are undergoing other treatment modalities or investigational agents for their cNF lesions
* Individuals who cannot give informed consent or adhere to study schedule
* Actively tanning during the course of the study
* Adverse reactions to compounds of any external agent (e.g., gels, lotions or anesthetic creams) required for use in the study, if no alternative to the said agent exists;
* Known allergy to injectable anesthetics or deoxycholic acid
* Any condition which, in the Investigator's opinion, would make it unsafe (for the participant or study personnel) to treat the participant as part of this research study;
* Pregnant females, due to possible discomfort with the procedure even though the procedure is localized and there is no new drug.
An Alternative Culture Medium to Better Support Preimplantation Embryo Development in Vitro

The purpose of this research study is to evaluate a newly developed embryo culture media system for human clinical use in ART.

Egg retrieval will be performed as per standard operating procedures. Eggs from a single patient are mixed together in a single group during the normal recovery and washing procedure following egg retrieval. The single group of eggs will be divided in half, then the embryologist will randomly place each half into one of the two culture media treatments, commercial or experimental. All mature eggs collected at retrieval will undergo fertilization per standard operating procedures according to physician recommendations. After fertilization (day 0), standard procedures involve in vitro embryo culture in a sequential two step media system. After confirmation of fertilization success on day 1, embryos are cultured until day 3 in step 1 medium (both commercial and experimental media are two step sequential culture systems). On day 3, embryos are evaluated and moved from step one to step two culture medium. On day 5 and day 6, embryo development will be assessed. Good quality blastocysts will either be transferred fresh or cryopreserved for later transfer and/or genetic testing.

Eligibility Criteria:
Inclusion Criteria:

* Adult women of any age who come to Colorado Center for Reproductive Medicine for fertility treatment using IVF.
* Patients can be of any race, culture, sexual orientation or ethnicity.

Exclusion Criteria:

* Minors are excluded from the study
Donor Stem Cell Transplant Followed by Cyclophosphamide in Treating Patients With Hematological Diseases

This pilot clinical trial studies donor stem cell transplant followed by cyclophosphamide in treating patients with hematological diseases. Giving chemotherapy before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Giving cyclophosphamide after the transplant may stop this from happening.

PRIMARY OBJECTIVES:

I. To determine if haploidentical stem cell transplant using post-transplant cyclophosphamide results in 60% or better disease free survival (DFS) at 12 months at our institution.

SECONDARY OBJECTIVES:

I. To determine the rate of acute and chronic graft-versus-host disease (GvHD), non-relapse mortality, and relapse.

OUTLINE:

PREPARATIVE REGIMEN: Patients receive fludarabine phosphate intravenously (IV) once daily (QD) on days -6 to -2. Patients receiving myeloablative conditioning receive busulfan IV every 6 hours for 16 doses on days -7 to -4 and patients receiving reduced intensity conditioning receive busulfan IV every 6 hours for 8 doses on days -5 to -4. Patients also receive cyclophosphamide IV QD on days -3 and -2

TRANSPLANT: Patients undergo stem cell transplant on day 0.

GVHD PROPHYLAXIS: Patients receive cyclophosphamide QD on days 3 and 4, tacrolimus on days 5-180, and mycophenolate mofetil on days 5-35.

After completion of study treatment, patients are followed up periodically for 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a hematological malignancy requiring an allogeneic stem cell transplant consistent with the standard of care
* Remission of any acute hematologic malignancy or adequate disease control for chronic malignancies.
* Ages 18-69 years old.
* Available familial haploidentical (4 to 6 out of 8 HLA loci-matched) donor

Exclusion Criteria:

* Significant organ dysfunction defined as: LV EF \< 50% (evaluated by echocardiogram or MRI), DLCO or FEV1 \< 65% predicted, AST/ALT \> 2.5 x ULN, Bilirubin \> 1.5 x ULN, Serum creatinine \> 2mg/dL, dialysis, or prior renal transplant
* HIV positive (Recipients who are positive for hepatitis B (HBV), hepatitis C (HCV) or human T-cell lymphotropic virus (HTLV-I/II) are not excluded from participation)
* Positive pregnancy test for women of childbearing age.
* Major anticipated illness or organ failure incompatible with survival form transplant.
* Severe psychiatric illness or mental deficiency sufficiently severe as to make compliance with the transplant treatment unlikely and informed consent impossible.
Improved Self Management in Uncontrolled Systolic Hypertension

Patients who receive smartphone-assisted health coaching will have a significantly lower 24 hour ambulatory blood pressure mean than patients who receive just health coaching

Primary Outcome Measure: Mean 24 hour ambulatory blood pressure

Secondary Outcome Measures: Profile of Mood States-SF Vigor Scale; Satisfaction with Life Scale; Positive and Negative Affect Schedule; Hospital Anxiety and Depression Scale; SF - 12

Eligibility Criteria:
Inclusion Criteria:

* 25 - 70 years old;
* mean daytime systolic BP\> 130 mm. Hg.

Exclusion Criteria:

* Severe or end-stage organ disease (liver, kidney, heart, lung) or history of diabetic ketoacidosis, or any other illness with expected survival less than 1 year;
* severe cognitive impairment;
* diagnosed psychiatric illness or disability;
* clinical significant cardiac arrhythmia;
* symptomatic orthostatic hypertension;
* pregnancy;
* not fluent in english.
Validation of the Spasticity Related Quality of Life Questionnaire

The purpose of the study is to describe the psychometric properties (validity, reliability and responsiveness) of the SQOL-6D instrument in the context of routine clinical treatment of upper limb spasticity.

The study qualifies as interventional not because of the use of an investigational product, but because the imposed specific data collection procedures include multiple questionnaire assessments and one on-site visit not necessarily part of routine clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Currently resident in the UK
* Subjects with a diagnosis of ULS
* Receiving a treatment at the enrolment visit, as part of their routine clinical management, aiming at reducing spasticity
* Sufficient grasp of English and cognitive ability to be able to understand the SQOL-6D questions, give informed consent and complete the protocol requirements as judged by the investigator

Exclusion Criteria:

* The subject has already been included in the study
* The subject, in the opinion of the investigator, would be unable to understand the questionnaire or to comply with the requirements of the study
Pilot Study of [68Ga]Ga-ABY-025 Imaging in Patients Undergoing Treatment with HER2-targeted Therapy

The purpose of this study is to determine if the radiotracer, \[68Ga\]Ga-ABY-025, used for PET imaging can help us better identify and visualize lesions or tumors, in patients who are receiving standard of care therapy HER2+ cancers.

This study will assess a dose of ABY-025 followed by a tracer dose of \[68Ga\]Ga-ABY-025 in subjects with HER2+ solid cancers, or HER2+ or low breast cancer undergoing or planning to undergo treatment with standard-of-care HER2-targeted therapy for an FDA-approved indication. The study drug will be administered on Day 0, and \[68Ga\]Ga-ABY-025 PET/CT scan will be obtained the same day after injection of study drug. Patients will receive a phone call from a study coordinator post-injection to assess for adverse events. Subjects will undergo standard of care evaluation of their advanced disease per the discretion of their treating physician.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>/= 18 years.
2. Patients with unresectable locally advanced or metastatic cancer who are eligible for standard of care treatment with HER2-targeted therapy per the discretion of their treating physician for an FDA-approved indication. Patients may be actively undergoing or planning to start HER2-targeted therapy at the time of study enrollment.
3. Must have a previous biopsy demonstrating HER2 expression in at least one lesion (HER2+ patients or breast cancer patients who are HER2+ or HER2-low) as defined by IHC and FISH studies or with HER2 amplification as defined by a liquid biopsy that was done as standard of care testing for the patient's cancer type.
4. Measurable disease on CT, FDG-PET, or MRI imaging for RECIST evaluation; patient must have measurable disease outside the liver.
5. Life expectancy of at least 6 months. Patients with brain metastases are permitted to enroll on this study.

Exclusion Criteria:

1. Measurable sites of disease only in the liver.
2. Inability to comply with study procedures.
3. Hypersensitivity or allergy to any component of \[68Ga\]Ga-ABY-025.
4. Pregnant or breastfeeding.
5. HER2-negative cancers that have no FDA approved indication for treatment with HER2-directed therapy.
6. Inability to lie flat for 30 minutes during an imaging session.
7. Medical or psychiatric co-morbidities that, in the opinion of the treating physician, would prevent the patient from successfully participating in the study.
Nicotine Treatment for Pulmonary Sarcoidosis: A Clinical Trial Pilot Study

The purpose of this study is to determine if nicotine treatment is beneficial for the treatment of sarcoidosis. Sarcoidosis is a disease of unknown cause that leads to inflammation. This disease affects your body's organs.

Participants will be randomly divided into two groups. One group will receive a nicotine patch to use for approximately 7 months; the other group will receive placebo for nicotine patches to use for the same time period.

Both groups will be contacted weekly by phone for the first 3 weeks then monthly for the duration of the study to monitor for any side effects.

The following information and samples will be collected:

Questionnaires Medical History Spirometry CT Scans Physical Exam Blood Samples for nicotine and nicotine metabolites

Eligibility Criteria:
Inclusion Criteria:

* Adult male and female subjects ≥ 18 to ≤ 75 years of age will be screened for eligibility.
* Eligible adult patients will have histologically proven sarcoidosis, diagnosed at least 6 months before screening, evidence of parenchymal disease on chest radiograph, an FVC between 50% and 85% of the predicted value, and a Medical Research Council dyspnea score (47) of at least grade 1.
* Patients must have been treated with at least 10 mg/day of prednisone or equivalent or one or more immunomodulating agents (hydroxychloroquine, methotrexate, azathioprine, leflunomide) for \>3 months before screening.
* Doses of these medications must be stable for at least 1 month before study entry.
* During the study, background medication regimen and doses are to remain stable.

Exclusion Criteria:

* active tobacco smoking or use of smokeless tobacco products containing nicotine,
* active cardiac or central nervous system disease,
* history of adverse reaction to nicotine or nicotine-containing products,
* patients with extensive irreversible pulmonary fibrosis (based upon lung biopsy or high resolution CT scan criterion) or inability to provide consent.

The subject will be excluded if they have a smoking history of greater than 20 pack years, or a diagnosis of other significant respiratory disorder other, than sarcoidosis that, in the opinion of the investigator, would complicate the evaluation of response to treatment; or, history of substance abuse (drugs or alcohol) within 3 years prior to screening or other circumstances (e.g., psychiatric disease) that could interfere with the subject's adherence to protocol requirements or increase their risk of drug (nicotine) dependence.