cyrilzakka/clinical-trials huggingface dataset:
A Study to Analyse the Immediate Effect of Dry Needling and Extra Corporeal Shock Wave Therapy on Hand Grip Strength

An argument to analyse the Immediate effect of dry needling or extra corporeal shock wave therapy on hand grip strength in normal healthy individuals with a hypothesis of dry needling or shock wave on forearm muscles have influence on the hand grip strength.

After written consent obtained from all the participants randomization and allocation will be done with sealed non transparent envelopes and participants will be assign to two groups Dry needling(DN) and Extra corporeal shock wave therapy (ESWT).Pre and post data of hand grip strength measured with Jamar hand dynamometer.Post data shall be collected precisely after 1 hr of intervention from both groups.

Eligibility Criteria:
Inclusion Criteria:

* No pain on the visual analog scoring scale of 100 mm scale,
* Muscle power of 4+ on oxford manual muscle testing of forearm and wrist extrinsic and intrinsic muscles
* Full range of motion in all dominant upper extremity joints.

Exclusion Criteria:

* History of previous fractures of the dominant upper extremity,
* Teno-synovitis of flexor tendons ,
* Dequervains synovitis,
* Left hand dominance.
Treatment Efforts Addressing Child Weight Management by Unifying Patients, Parents & Providers

The US Preventive Services Task Force (USPSTF) recommends that providers screen children aged 6 years and older for obesity and offer or refer them to a comprehensive behavioral intervention (≥26 hours over a period of up to 12 months) to promote improvement in weight status. Family-based behavioral treatment (FBT) is an effective treatment that targets both child and parents and meets the USPSTF recommendations. By contrast, the American Medical Association (AMA) recommends a staged approach to childhood obesity screening and counseling, which begins with prevention counseling by the primary care provider (PCP) and includes assessment of weight status, patient/family motivation and readiness to change, promotion of healthy eating and activity habits, and use of health behavior change strategies. Our study compares a staged approach enhanced standard of care (eSOC) vs. eSOC + FBT, to provide families and PCPs with information on the best intervention approach for the behavioral treatment of childhood obesity. Our project seeks to fill the gap in the evidence on family-based weight management in primary care settings among diverse and underserved populations with a special focus on Black children, families insured by Medicaid, and sex differences.

Note: our enrollment number includes two participants (one child and one parent) from each enrolled family.

Eligibility Criteria:
Inclusion Criteria for children include:

* have a BMI percentile ≥95th for age and sex;
* comfortable speaking English language;
* able to provide written or verbal (based on age) informed assent;
* willing to change diet, physical activity, and/or weight;
* patient of a participating clinic/practice; and
* able to participate in scheduled sessions.

Inclusion Criteria for parents include:

• comfortable speaking and reading English language.

Exclusion Criteria include:

* families who plan to no longer have the child be a patient of any participating clinic/practice during any point in the 18-month study period;
* children with chronic conditions or on medications that substantially impact or interfere with growth, appetite, weight, or physical activity participation;
* families for whom the Primary Care Provider (PCP) or site PI thinks the intervention is clinically/medically inappropriate (e.g., developmental delay, or emotional or cognitive difficulties, if the PI/PCP believes these factors will interfere with study/intervention participation); and
* families in whom the parent or child exhibits eating disorder symptomatology.
Blue Light Emitting Diode Therapy on Vulvovaginal Candidiasis

With the knowledge that VVC is an infectious disease of the genitourinary tract that is common in women of reproductive age, and because of the shortage of non-drug therapies for this condition, this study will aim to evaluate the effect of ultraviolet A/blue LED with a wavelength of 401 ± 5 nm in patients with a clinical manifestation of candidiasis and its ability to prevent recurrence.

Vulvovaginal candidiasis (VVC) is an infection of the vulva and vagina caused by the abnormal growth of several Candida species. This pathology is one of the most common diagnoses in gynecological practice and the second most common genital infection. Studies have shown that 15 to 25% of adult women present with fungal colonization despite being asymptomatic and that 75% of them will develop the disease at some point in their lives.

The treatment of VVC involves the use of antifungal agents, either orally or topically, which resolves 80 to 90% of the cases. However, the use of these agents can lead to the development of adverse reactions such as dysuria, pruritus, and gastrointestinal disorders.

Accordingly, a hypothesis arises that the blue/violet light- emitting diode (LED) may be an alternative treatment for women with VVC because of its antimicrobial effect that has been proven by several studies. Moreover, it is considered a safe, non-invasive, painless, and non-toxic technique for use in several types of tissue.

Eligibility Criteria:
Inclusion Criteria:

subject selection will be according to the following criteria:

1. Age will range between 18- 50 years.
2. All patients will be confirmed by culture and examination of fresh vaginal samples, to have VVC.
3. All patients who will be enrolled to the study will have their informed consent.

Exclusion Criteria:

The participants will be excluded if they meet one of the following criteria:

1. Individuals on any other antifungal drugs.
2. Individuals with cardiopulmonary conditions.
3. Individuals undergoing another radiation therapy.
4. Sensory impairment
Sequential Administration of FE75C and Docetaxel Versus Docetaxel/Cyclophosphamide in HER-2 Negative, Node Positive Breast Cancer

In this trial investigators propose to assess the dose dense, G-CSF supported sequential administration of 4 cycles of FEC followed by 4 cycles of docetaxel versus 6 cycles of docetaxel/cyclophosphamide as adjuvant chemotherapy in women with HER-2 negative, axillary lymph node positive breast cancer

Anthracycline-containing regimens are recommended as adjuvant treatment for women with node positive breast cancer. At least five large randomized clinical trials demonstrated that the addition or sequential administration of a taxane (paclitaxel or docetaxel) to an anthracycline-based regimen resulted in superior clinical outcome for women with node positive or high risk node-negative early breast cancer. In two large randomized studies the dose dense administration with G-CSF support of anthracycline-based and paclitaxel combination was superior to the same regimen administered every three weeks without growth factors as adjuvant therapy in women with axillary node positive breast cancer. In one randomized trial, docetaxel was proved superior to paclitaxel in women with metastatic breast cancer.

Data from at least one trial suggest that four cycles of a non-anthracycline but taxane-containing adjuvant regimen (docetaxel plus cyclophosphamide) provide outcomes that are at least as good, if not better than four cycles of doxorubicin/cyclophosphamide combination.

Eligibility Criteria:
Inclusion Criteria:

* Women with histologically-confirmed unilateral invasive ductal or lobular breast adenocarcinoma
* Within 60 days after the surgical excision of the primary tumor with tumor-free operation margins; at least 10 axillary lymph nodes have to be removed.
* Tumor involvement of at least one axillary lymph node
* Absence of any clinical or radiological evidence of local or metastatic disease
* Premenopausal or postmenopausal women aged 18-75 years old
* Adequate bone marrow function (absolute neutrophil count \>1500/mm3, platelet count \>100.000/mm3, hemoglobin \>10gr/mm3)
* Adequate liver (bilirubin \<1.0 times upper limit of normal and SGOT/SGPT \<2.5 times upper limit of normal) and renal function (creatinine \<1.5mg/dl)
* Adequate cardiac function (LVEF\>50%)
* Written informed consent

Exclusion Criteria:

* Positive pregnancy test.
* Psychiatric illness or social situation that would preclude study compliance.
* Other concurrent uncontrolled illness.
* Prior or concurrent antineoplastic therapy e.g. hormonal therapy, radiation therapy, chemotherapy, biological agents.
* Previous history of other invasive malignancy other than non-melanomatous skin cancer.
A Retrospective Review Evaluating the Matrix Pro Applicator for Treatment of Wrinkles

This is a retrospective chart review of data from the multi-site prospective clinical trial, "Functional Usability and Feasibility Testing of the Profound Matrix™ System (FUFT2002)" to evaluate the safety and efficacy of the Profound Matrix System Matrix Pro applicator for the treatment of wrinkles.

This was a retrospective medical record review of subject data from the source study FUFT2002 to evaluate the safety, efficacy, tolerability, and usability of the Profound MatrixTM System with the Matrix Pro Applicator for the treatment of wrinkles.

Eligibility Criteria:
Inclusion Criteria:

1. Met eligibility criteria under source study FUFT2002 and enrolled into FUFT2002 study (NCT # pending).
2. Received full face treatment with 27W Matrix Pro applicator only.
3. Have baseline and follow-up assessments obtained.
4. Have photography obtained with the VISIA standardized camera system (Appendix III).

Exclusion Criteria:

1. Sun exposure during the course of the study.
2. Aesthetic procedures and/or treatments during the course of the study.
3. Any violation of study treatment instructions.
4. Upon inspection, any differences in baseline and follow up photos that would not make evaluation of photos viable (e.g. chin placement, facial expression).
5. Any protocol deviation or change in study visit activities that would jeopardize reliability or validity of the retrospective review
Extension Study of the Family Spirit Program

The aim of the proposed research is to implement and evaluate a follow-up study of the impact of the Family Spirit family strengthening program among a high-risk sample of Apache mothers and their children. The Family Spirit intervention is a 52-session home-visiting curriculum administered by American Indian paraprofessionals to young mothers from 28 weeks gestation through the child's first 3 years of life. In a series of pilot studies and a recently completed randomized controlled trial, the Family Spirit intervention has been found to positively impact several maternal, parenting and child outcomes up through three years postpartum. In the proposed study, the investigators will implement the Family Spirit intervention to young mothers (12-20 years at conception), with revisions to several assessment measures and to the curriculum such that the substance abuse prevention curriculum modules will be taught earlier than in the original study.

This is a single group pre-post study designed to evaluate the impact of a home visiting intervention in improving parenting self-efficacy and a number of other maternal and child health and behavioral outcomes among a sample of young mothers, including maternal substance use. The Family Spirit intervention consists of 52 sessions (30-60 minutes in duration) delivered during a 39-month intervention phase. All sessions are designed to be taught at the participant's home, but they may also occur at another location chosen by the participant (e.g. study office, vehicle). Outcome data will be collected at Baseline and at 2 months, 6 months, 12 months, 24 months and 36 months postpartum.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant American Indian female less than or equal to 32 weeks gestation.
* Reside within 60 miles of Whiteriver Indian Health Service unit.
* Age 12-20 years of age at time of conception

Exclusion Criteria:

* Completed previous randomized controlled trial of Family Spirit
* ≤11 years old or ≥21 years old at time of conception of index pregnancy.
Establishment of a Decision Aid Tool for Asymptomatic Small Leiomyoma and Analysis of Influencing Factors for Clinical Decision-making Using HIFU

With the younger patients diagnosed with asymptomatic leiomyoma, delay in the reproductive age of women, the advancement of medical technology, and the rapid development of treatment methods, there are many choices between gynecologists, gynecologists and patients because of experience and knowledge. It is not easy to make the most favorable choice for patients. This study is mainly led by a committee composed of designers, doctors, nurses and patients, and based on clinical guidelines and evidence-based medicine. Co-operating with patients with asymptomatic small leiomyoma, we want to find the influencing factors of clinical decision-making, and to establish a patient decision aid tool. We use prospective trial to verify that the use of this tool can improve patients' decision-making efficacy and further improve patient-reported outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of leiomyoma: patients with leiomyoma diagnosed by imaging examinations (ultrasound and MRI) have no clinical symptoms;
2. Female with age in 18-55 years old;
3. The maximum diameter of a single leiomyoma is less than 5m, and the number does not exceed 10 by MRI;
4. No contraindications for sedation and analgesia;
5. Patients and their families agree to join this study, and can follow up on time.

Exclusion Criteria:

1. History of myomectomy, including transabdominal, laparoscopic, hysteroscopy, etc.;
2. History of connective tissue diseases or radiotherapy, especially abdominal radiotherapy;
3. With pregnancy, acute inflammation of the reproductive tract, or other gynecological benign and malignant diseases such as endometriosis and ovarian tumors;
4. The maximum diameter of leiomyoma is greater than or equal to 5cm;
5. Suspected malignant tumor, such as sarcoma;
6. Those with language communication barriers and unable to cooperate with sedative and analgesic programs;
7. Abdominal scarring, when diagnosed by ultrasound transabdominal scan, has obvious sound attenuation (more than 10mm range).
Photodynamic Therapy in Treating Patients With Stage III or Stage IV Melanoma

RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. Photodynamic therapy may be effective in treating melanoma.

PURPOSE: Phase I/II trial to study the effectiveness of photodynamic therapy in treating patients who have stage III or stage IV melanoma.

OBJECTIVES: I. Determine the safety of photodynamic therapy with verteporfin and Detox-B adjuvant in patients with stage III or IV melanoma. II. Determine the clinical response in patients treated with this regimen. III. Determine whether this regimen induces systemic cellular and humoral immune responses to melanoma antigens in these patients. IV. Determine the ablation of cutaneous tumors in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients undergo photodynamic therapy with verteporfin and Detox-B adjuvant. Treatment repeats every 2 weeks for a total of 3 courses, each to a different melanoma lesion. Both non-treated and treated tumors are measured prior to study and at months 2, 4, and 6. Immune profile is also assessed prior to study and at months 2, 4, and 6.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 12 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Diagnosis of stage III or IV melanoma At least 3 cutaneous tumors for treatment (treatment tumors) AND 1-7 additional cutaneous, visceral, or lymph node tumors for response assessment (marker tumors) Treatment tumors must be on trunk, arms, or legs AND be 1.0-3.6 cm in longest dimension Measurable disease by calipers or CT scan No CNS metastases by CT scan

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 2,500/mm3 Neutrophil count at least 1,000/mm3 Platelet count at least 50,000/mm3 Hemoglobin at least 9 g/dL Hematocrit at least 27% Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) AST/ALT no greater than 2 times ULN Alkaline phosphatase no greater than 2.5 times ULN Renal: Creatinine no greater than 2 times ULN

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy or immunotherapy No concurrent biologic therapy Chemotherapy: At least 4 weeks since prior chemotherapy No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery: No concurrent surgical removal of melanoma lesions designated for treatment or response assessment Other: No other concurrent therapy for melanoma
Pericapsular Nerve Group Block for Total Hip Arthroplasty

Controlling pain after hip replacement surgery improves comfort and partient satisfaction. Pain after hip replacement has traditionally been managed using systemic pain medications including acetaminophen and non-steroidal anti-inflammatory drugs. A recent Cochrane review demonstrated that compared to systemic analgesia alone, peripheral nerve blocks reduce postoperative pain with moderate-quality evidence. Pericapsular Nerve Group block is a new technique allowing local anesthetic diffusion to femoral, obturator and accessory obturator nerves and providing a good analgesic effect for hip fracture surgery. Investigators hypothesized that the PENG block could be an interesting alternative to systemic analgesiscs for pain control after total hip replacement.

The aim of the study was to evaluate the efficacy of the PENG block for intra and postoperative pain control in total hip arthroplasty.

it was a monocentric, randomized, controlled and double blind study. Patients scheduled for primary THA with lateral approach under general anesthesia.

Premedication with IV midazolam 1 to 2 mg on arrival to operating theatre. general anesthesia was conducted using fentanyl, propofol and cisatracurium for induction and isoflurane for maintanance patients were randomized using a random table in two groups:

* PENG Block group (PG) who received 2 mg.kg-1Ropivacaine in 40 ml of saline.
* Placebo group (SG) who received 40 ml of saline.

Postoperative analgesia started before extubation of the patient, with:

* IV paracetamol 1g/6h in Day1 and oral paracetamol 1g/8h for 6 days.
* non steroidal anti inflammatory drugs with IM piroxicam 20 mg on day one (at the end of surgery) and oral diclofenac 50 mg/12h for 3 days.
* Morphine PCA for day 1 (24 H) and oral tramadol 50 mg/12h from day 2 to day 6.

Eligibility Criteria:
Inclusion Criteria:

* primary THA with lateral approach under general anesthesia.

Exclusion Criteria:

* Hip fracture,
* allergy to local anesthetics,
* peripheral neuropathy,
* creatinin clearance inferior to 30ml/min,
* weight inferior to 50 Kg or superior to 100 Kg,
* neurological disorder affecting the lower extremity, significant psychiatric conditions,
* patients receiving corticosteroid therapy,
* chronic consumption of opioids (\>2 months).
PACE CALL: Weight Loss Study for Childhood Leukemia Survivors

UC San Diego researchers conducted a study to develop and evaluate an internet and text message based weight loss study for childhood acute lymphoblastic leukemia (ALL) survivors. We hypothesized that those study participants randomized to the intervention will demonstrate greater reduction in BMI-z score as compared to the control group.

The PACE CALL or Fit4Life study, sponsored by the American Cancer Society , was a 4-year research project aimed at developing and testing the efficacy of a web \& cell phone based weight loss program. The purpose of the intervention was to promote weight loss and management and improve physical activity, diet and sedentary behaviors among preadolescent and adolescent youth (7-18) who are survivors of childhood ALL (defined as being off therapy for at least 2 years without disease relapse). Fit4Life was based on and adapted from notable prior successful adolescent weight control interventions, and physical activity and diet behavioral promotion interventions in the preadolescent and adolescent age group. Particular sensitivity to issues experienced by cancer survivors and their families were incorporated into this newly developed intervention based on systematic cancer survivor input and feedback as well as mentor/collaborator input regarding cancer survivor research.

Eligibility Criteria:
Inclusion Criteria:

* 7 - 18 years old
* survived childhood acute lymphoblastic leukemia (defined as being off treatment for at least 2 years)
* greater than or equal to 85th percentile BMI-for-age and gender)
* read and speak English
* have a parent that reads and speaks English or Spanish
* willingness to attend assessments
* access to the Internet

Exclusion Criteria:

* any comorbidities of obesity that require immediate sub-specialist referral including pseudotumor cerebri, sleep apnea, and obesity hypoventilation syndrome
* any subject with a known disease of the liver, pancreas or small intestine that would adversely effect digestion or absorption of nutrients
* any pulmonary, cardiovascular, orthopedic, or musculoskeletal problem that would limit ability to adhere to moderate-level physical activity recommendations
* have a history of substance abuse or other psychiatric disorder that would impair compliance with the study protocol
* are using any medications which alter body weight
* are currently enrolled in another weight loss program
* in foster care
Fistura® Procedure for the Treatment of Complex Anal Fistulas

This study aims to evaluate the healing rate of complex fistulas using radiofrequency (Fistura® procedure), in a prospective, interventional, monocenter, single-arm design.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with complex fistulas

   Complex fistulas include trans-sphincteric fistulas involving more than 30% of the external sphincter, supra-sphincteric fistulas, extra-sphincteric fistulas, horseshoe fistulas, fistulas involving multiple tracts (according to the ASCRS) and fistulas with a curved tract or a tract presenting diverticula, for which:

   Suppuration is described by the patient and/or visible by an opening in the anal margin or by anoscopy Clinical symptoms led to an MRI demonstrating the path Fistula path demonstrated in the acute phase during drainage of an abscess
2. Patient ≥ 18 years at study entry
3. Patients with a previously drained fistula, without diverticula \> 10 mm, without T2 hyperintensity (assessed by MRI). Drainage is achieved by placing a seton, usually from 10 weeks to 12 months prior to the procedure
4. Patient and investigator signed and dated the informed consent form prior to the procedure

Exclusion Criteria:

1. Patient \< 18 years at study entry
2. Patient has a known contraindication to treatment using radiofrequency (infectious anal pathologies, anal fissures, residual Longo anterior treatment staples)
3. Patient has a known contraindication to MRI
4. Simple fistulas defined as inter-sphincteric or trans-sphincteric, involving less than 30% of the total height of the sphincter apparatus (attested by MRI, ASCRS classification)
5. Patient has a fistula associated with radiation and inflammatory bowel disease
6. Patient is unable/unwilling to provide informed consent
7. Patient is unable to comply with the protocol or proposed follow-up visits and questionnaires
8. Patient is currently participating in another clinical study
9. Patient is pregnant